PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
FDA 510(k) clearance K946080 · decided 1995-08-02
Clearance details
- K-number
- K946080
- Device name
- PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
- Applicant
- Portable Power Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-13
- Decision date
- 1995-08-02
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- FCO
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Castle Rock, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 (K944348) | R & D Batteries, Inc. | 1995-03-23 |
| R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 (K944389) | R & D Batteries, Inc. | 1995-03-23 |
| R&D PART NOS. 5490, 5541, 5358, 5497 (K945870) | R & D Batteries, Inc. | 1995-03-23 |
| R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 (K944388) | R & D Batteries, Inc. | 1995-03-23 |
| RECHARGEABLE BATTERIES (K944521) | R & D Batteries, Inc. | 1995-03-06 |
| R&D PART NOS. 5262, 5543, 5432, 5469 (K945868) | R & D Batteries, Inc. | 1995-03-06 |
| R&D BATTERIES PART NOS. 5186 AND 5230 (K944387) | R & D Batteries, Inc. | 1995-03-02 |
| R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 (K944390) | R & D Batteries, Inc. | 1995-02-27 |
| R&D PART NOS. 5339, 5510, 5514 (K945871) | R & D Batteries, Inc. | 1995-02-27 |
| R&D PART NOS. 5443, 5322, 5448, 5492 (K945869) | R & D Batteries, Inc. | 1995-02-27 |
| R&D BATTERIES PART NOS. 5354 AND 5150 (K944386) | R & D Batteries, Inc. | 1994-12-30 |
| R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 (K944294) | R & D Batteries, Inc. | 1994-12-30 |
Recalls involving this device
No recalls on record reference this clearance.