The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Pump Max (110vac), Penumbra Pump Max (230vac), Penumbar Pump Max Canister/tubing.
| Device ID | K122756 |
| 510k Number | K122756 |
| Device Name: | PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Seth Schulman |
| Correspondent | Seth Schulman PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-07 |
| Decision Date | 2012-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548013343 | K122756 | 000 |
| 00814548012773 | K122756 | 000 |
| 00814548012698 | K122756 | 000 |
| 00814548010038 | K122756 | 000 |
| 00814548010021 | K122756 | 000 |
| 00814548010014 | K122756 | 000 |