POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10— 510(k) K934067
Substantially EquivalentNational Custom Ent., Inc.
FDA 510(k) clearance K934067 for POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10, Substantially Equivalent on 1993-10-07. Applicant: National Custom Ent., Inc.. Device class: 3.
Clearance details
- Applicant
- National Custom Ent., Inc.
- Product code
- Code DRK
- Device class
- Class 3
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.