Megadyne Patient Return Electrode Pad – Universal Dual (model 0846), Megadyne Patient Return Electrode Pad – Universal Plus (model 0847), Megadyne Patient Return Electrode Pad – Universal Dual Plus (model 0848) (K233644)
Description
Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) by Megadyne Medical Products, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233644
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Megadyne Patient Return Electrode Pad – Universal Dual (model 0846), Megadyne Patient Return Electrode Pad – Universal Plus (model 0847), Megadyne Patient Return Electrode Pad – Universal Dual Plus (model 0848) (K233644) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE | Megadyne Medical Products, Inc. | 2014 |
Trace the full predicate network for K233644
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.