FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MARK I HUMIDIFIER
K Number: K932570
·
Decision Aug 25, 1993
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- MARK I HUMIDIFIER
- K Number
- K932570
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.F. Electronics, Inc.
- Date Received
- May 27, 1993
- Decision Date
- August 25, 1993
- Product Code
- BTT
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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