FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CD-102 CARBON DIOXIDE ANALYZER/RECOR
K Number: K833739
·
Decision Dec 16, 1983
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
20
Review Days
52
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Basic Information
- Device Name
- CD-102 CARBON DIOXIDE ANALYZER/RECOR
- K Number
- K833739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Instrumentarium Corp.
- Date Received
- October 25, 1983
- Decision Date
- December 16, 1983
- Product Code
- CCJ
- 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 |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Instrumentarium Corp.
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|---|---|---|---|
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| K992385 | ORTHOPANTOMOGRAPH OP100D | Sep 28, 1999 | Substantially Equivalent |
| K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ | Jul 17, 1998 | Substantially Equivalent |
| K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS | Apr 4, 1997 | Substantially Equivalent |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | Apr 30, 1996 | Substantially Equivalent |
| K955018 | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Jan 30, 1996 | Substantially Equivalent |
| K934478 | ALPHA STEREO | Jan 31, 1995 | Substantially Equivalent |
| K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE | Jul 22, 1993 | Substantially Equivalent |