FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
K Number: K934067
·
Decision Oct 7, 1993
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
12
Review Days
48
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Basic Information
- Device Name
- POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
- K Number
- K934067
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- National Custom Ent., Inc.
- Date Received
- August 20, 1993
- Decision Date
- October 7, 1993
- Product Code
- DRK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRK | Dc-Defibrillator, High Energy, (Including Paddles) | FDA class 3 | Cardiovascular |
Other Clearances by National Custom Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012264 | MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC | Oct 10, 2001 | Substantially Equivalent |
| K012263 | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 | Oct 10, 2001 | Substantially Equivalent |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | Sep 12, 2001 | Substantially Equivalent |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | Sep 12, 2001 | Substantially Equivalent |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | Sep 12, 2001 | Substantially Equivalent |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC | Sep 10, 2001 | Substantially Equivalent |
| K943680 | NCE REPLACEMENT BATTERIES | Nov 4, 1994 | Substantially Equivalent |
| K943632 | REPLACEMENT BATTERIES | Nov 4, 1994 | Substantially Equivalent |
| K942629 | NCE REPLACEMENT BATTERIES | Aug 18, 1994 | Substantially Equivalent |
| K941995 | NCE REPLACEMENT BATTERIES | Jul 26, 1994 | Substantially Equivalent - Subject to Tracking Reg. |