FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
K Number: K902021
·
Decision Oct 9, 1990
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
21
Applicant Total
1
Review Days
159
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Basic Information
- Device Name
- RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
- K Number
- K902021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Albion Instruments
- Date Received
- May 3, 1990
- Decision Date
- October 9, 1990
- 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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