FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE HARVARD LIBRARY
K Number: K970678
·
Decision Jan 9, 1998
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
9
Review Days
319
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Basic Information
- Device Name
- THE HARVARD LIBRARY
- K Number
- K970678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Harvard Apparatus, Inc.
- Date Received
- February 24, 1997
- Decision Date
- January 9, 1998
- Product Code
- MRZ
- 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Harvard Apparatus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952794 | HARVARD 2 SYRINGE PUMP | Sep 15, 1995 | Substantially Equivalent |
| K903614 | HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE | Dec 14, 1990 | Substantially Equivalent |
| K903613 | HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) | Nov 7, 1990 | Substantially Equivalent |
| K813644 | MODEL 2650 HIGH CAPACITY DUAL SYRINGE | Feb 18, 1982 | Substantially Equivalent |
| K801904 | SYRINGE INFUSION PUMP #2716 | Aug 27, 1980 | Substantially Equivalent |
| K800569 | SYRINGE INFUSION PUMP #2720 | Apr 8, 1980 | Substantially Equivalent |
| K791293 | BATTERY POWERED SYRINGE INFUSION PUMP | Nov 13, 1979 | Substantially Equivalent |
| K780705 | INFUSION PUMP-MODEL 2616 | May 19, 1978 | Substantially Equivalent |