The following data is part of a premarket notification filed by Sorenson Medical, Inc. with the FDA for Ambit Push & Play Ambulatory Infusion Pump.
| Device ID | K052221 |
| 510k Number | K052221 |
| Device Name: | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320 |
| Contact | Douglas Bueschel |
| Correspondent | Douglas Bueschel SORENSON MEDICAL, INC. 1375 WEST 8040 SOUTH West Jordan, UT 84088 -8320 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-15 |
| Decision Date | 2005-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00193494000684 | K052221 | 000 |
| 00193494000677 | K052221 | 000 |
| 00193494001483 | K052221 | 000 |
| 00193494001285 | K052221 | 000 |
| 00193494000851 | K052221 | 000 |
| 00193494000844 | K052221 | 000 |
| 00193494000837 | K052221 | 000 |
| 20193494000824 | K052221 | 000 |
| 00193494000646 | K052221 | 000 |