Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10
FDA 510(k) K934067 · National Custom Ent., Inc.
510(k) numberK934067
Submission
- Device name
- Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10
- Applicant
- National Custom Ent., Inc.
Burnsville, MN, US - Received
- August 20, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRK – Dc-Defibrillator, High Energy, (Including Paddles)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
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Questions and answers
When was Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10 cleared by the FDA?
Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10 (K934067) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 48 days after the submission was received.
What is the product code of K934067?
The FDA product code is DRK – Dc-Defibrillator, High Energy, (Including Paddles), a Class III (high risk) device regulated under 21 CFR 870.5300.