FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEEP VALVE
K Number: K961867
·
Decision Aug 13, 1996
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- PEEP VALVE
- K Number
- K961867
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Marketing Concepts
- Date Received
- May 15, 1996
- Decision Date
- August 13, 1996
- 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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| K961332 | BAGRIGHT RESPOSABLE INFANT RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961331 | BAGRIGHT RESPOSABLE CHILD RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961868 | RESPOSABLE CHILD RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961882 | RESPOSABLE INFANT RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K953546 | MANUAL PULMONARY RESUSICITATOR | Feb 29, 1996 | Substantially Equivalent |
| K954296 | BAGRIGHT RESUSCITATOR | Dec 20, 1995 | Substantially Equivalent |