510(k) K934067
- Device
- POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
- Applicant
- NATIONAL CUSTOM ENT., INC.
- 510(k) number
- K934067
- Product code
- DRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-10-07
- Date received
- 1993-08-20
- Regulation
- 870.5300
- Classification name
- Dc-defibrillator, High Energy, (including Paddles)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MIKE BENYO
- Address
- 400 Gateway Blvd. Burnsville MN US 55337 55337
FDA Registration Numbers#
- 2183890
Source Documents#
Legacy Summary#
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FDA Review#
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