FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPEN
K Number: K895890
·
Decision Feb 16, 1990
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
20
Review Days
134
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Basic Information
- Device Name
- AUTOPEN
- K Number
- K895890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- October 5, 1989
- Decision Date
- February 16, 1990
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| K894474 | THE AUTOLET LITE | Aug 18, 1989 | Substantially Equivalent |
| K885340 | AIR DISPLACEMENT PIPETTE | Feb 14, 1989 | Substantially Equivalent |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Feb 17, 1988 | Substantially Equivalent |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent |
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Dec 16, 1986 | Substantially Equivalent |