FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K Number: K831444
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
96
Review Days
130
Basic Information
- Device Name
- SINGLE USE SYRINGE #103 PERSONAL MEDIC
- K Number
- K831444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- PACESETTER SYSTEMS
- Date Received
- May 5, 1983
- Decision Date
- September 12, 1983
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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| K884733 | AFP MODEL 262T PULSE GENERATOR | Feb 10, 1989 | Substantially Equivalent |
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