MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
FDA 510(k) clearance K902288 · decided 1991-02-25
Clearance details
- K-number
- K902288
- Device name
- MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
- Applicant
- Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-22
- Decision date
- 1991-02-25
- Days to decision
- 279 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Physio-Control Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFE recall (Z-2311-2010) | Physio Control, Inc. | 2010-08-28 |
| Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/2 recall (Z-2312-2010) | Physio Control, Inc. | 2010-08-28 |