FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO-BETA U100 SYRINGE
K Number: K844796
·
Decision Dec 18, 1984
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
12
Review Days
7
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Basic Information
- Device Name
- MICRO-BETA U100 SYRINGE
- K Number
- K844796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Orange Medical Instruments, Inc.
- Date Received
- December 11, 1984
- Decision Date
- December 18, 1984
- 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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Other Clearances by Orange Medical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860808 | CONTINUCATH | Mar 13, 1986 | Substantially Equivalent |
| K851822 | BETA SCAN TRENDS METER | Oct 3, 1985 | Substantially Equivalent |
| K843882 | TRENDS LANCET | Nov 5, 1984 | Substantially Equivalent |
| K841369 | BETA SCAN DRYSTIX | Aug 23, 1984 | Substantially Equivalent |
| K833705 | BETAJECT BD U100 | May 9, 1984 | Substantially Equivalent |
| K833706 | CLICK-COUNT U100 INSULIN SYRINGE | Apr 5, 1984 | Substantially Equivalent |
| K832691 | BETA SCAN REAGENT STRIP | Nov 14, 1983 | Substantially Equivalent |
| K832793 | NEOCATH 1000 W/HEPCOTE | Sep 26, 1983 | Substantially Equivalent |
| K831897 | BETA I PROGRAMMABLE INFUSION PUMP | Aug 12, 1983 | Substantially Equivalent |
| K831523 | BETA SCAN NORMAL CONTROL SOLUTION | Jul 19, 1983 | Substantially Equivalent |