FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BETAJECT BD U100
K Number: K833705
·
Decision May 9, 1984
Classifications
1
FEI Numbers
466
Registration Numbers
466
Same Product Code
680
Applicant Total
12
Review Days
204
Basic Information
- Device Name
- BETAJECT BD U100
- K Number
- K833705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- ORANGE MEDICAL INSTRUMENTS, INC.
- Date Received
- October 18, 1983
- Decision Date
- May 9, 1984
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 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 |
| K844796 | MICRO-BETA U100 SYRINGE | Dec 18, 1984 | Substantially Equivalent |
| K843882 | TRENDS LANCET | Nov 5, 1984 | Substantially Equivalent |
| K841369 | BETA SCAN DRYSTIX | Aug 23, 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 |