BATTERY PACK
FDA 510(k) clearance K923864 · decided 1992-10-05
Clearance details
- K-number
- K923864
- Device name
- BATTERY PACK
- Applicant
- Portable Power Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-03
- Decision date
- 1992-10-05
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Castle Rock, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.