FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANDROS ANALYZERS AIRWAY ADAPTER
K Number: K852463
·
Decision Jul 8, 1985
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- ANDROS ANALYZERS AIRWAY ADAPTER
- K Number
- K852463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Andros Analyzers, Inc.
- Date Received
- June 10, 1985
- Decision Date
- July 8, 1985
- Product Code
- CCK
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Andros Analyzers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903806 | ANGIOTEC IMAGE MANAGEMENT SYSTEM | Nov 23, 1990 | Substantially Equivalent |
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | Jun 23, 1989 | Substantially Equivalent |
| K892869 | ANGIOTEC ZX DIGITAL IMAGE PROCESSOR | May 26, 1989 | Substantially Equivalent |
| K891485 | ANGIOTEC FMX-2220 SYSTEM | May 5, 1989 | Substantially Equivalent |