FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BORDON GAGE REGULATOR #BG
K Number: K823775
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
29
Review Days
31
Basic Information
- Device Name
- BORDON GAGE REGULATOR #BG
- K Number
- K823775
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2300
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- TIMETER INSTRUMENT CORP.
- Date Received
- December 14, 1982
- Decision Date
- January 14, 1983
- Product Code
- CCN
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K834274 | CRITERION I | Apr 13, 1984 | Substantially Equivalent |
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| K813235 | DISS FEMALE AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
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