FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEEP VALVE
K Number: K923618
·
Decision Aug 3, 1992
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- PEEP VALVE
- K Number
- K923618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Respiratory Systems, Inc.
- Date Received
- July 21, 1992
- Decision Date
- August 3, 1992
- 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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