LIFE PULSE TESUSCITATION TIMER
FDA 510(k) clearance K944667 · decided 1994-10-04
Clearance details
- K-number
- K944667
- Device name
- LIFE PULSE TESUSCITATION TIMER
- Applicant
- Green Field Medical Sourcing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-20
- Decision date
- 1994-10-04
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- PMK
- Device class
- 1
- Regulation number
- 870.5210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shrewsbury, MA, 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 |
|---|---|---|
| LIFE PULSE RESUSCITATION TIMER (K932867) | Green Field Medical Sourcing, Inc. | 1994-07-25 |
Recalls involving this device
No recalls on record reference this clearance.