The following data is part of a premarket notification filed by Block Medical, Inc. with the FDA for Verifuse Ambulatory Pump.
| Device ID | K934551 |
| 510k Number | K934551 |
| Device Name: | VERIFUSE AMBULATORY PUMP |
| Classification | Pump, Infusion, Pca |
| Applicant | BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Contact | Ian Kennedy |
| Correspondent | Ian Kennedy BLOCK MEDICAL, INC. 5957 LANDAU COURT Carlsbad, CA 92008 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-22 |
| Decision Date | 1994-03-17 |