POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
FDA 510(k) clearance K934067 · decided 1993-10-07
Clearance details
- K-number
- K934067
- Device name
- POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
- Applicant
- National Custom Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-20
- Decision date
- 1993-10-07
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- DRK
- Device class
- 3
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Burnsville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.