FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
K Number: K912240
·
Decision Aug 22, 1991
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
3
Review Days
93
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Basic Information
- Device Name
- CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM
- K Number
- K912240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Anesthesia Products
- Date Received
- May 21, 1991
- Decision Date
- August 22, 1991
- Product Code
- BYE
- 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 |
|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | FDA class 2 | Anesthesiology |
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