FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BATTERY PACK# S1009LA
K Number: K933065
·
Decision Feb 17, 1994
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
18
Review Days
240
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Basic Information
- Device Name
- BATTERY PACK# S1009LA
- K Number
- K933065
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Portable Power Systems, Inc.
- Date Received
- June 22, 1993
- Decision Date
- February 17, 1994
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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| K932823 | BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK | Feb 17, 1994 | Substantially Equivalent |
| K934015 | RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB | Feb 17, 1994 | Substantially Equivalent |
| K934508 | BATTERY PACK# S1024NC | Feb 17, 1994 | Substantially Equivalent |
| K931484 | REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S | Feb 17, 1994 | Substantially Equivalent |