FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
K Number: K923433
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
20
Review Days
374
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Basic Information
- Device Name
- AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
- K Number
- K923433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrumentarium Corp.
- Date Received
- July 13, 1992
- Decision Date
- July 22, 1993
- Product Code
- CBQ
- 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 |
|---|---|---|---|
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K930338 | ORTHOCEPH OC100 | Apr 27, 1993 | Substantially Equivalent |