FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALVE, PEEP
K Number: K760230
·
Decision Aug 6, 1976
Classifications
1
FEI Numbers
71
Registration Numbers
72
Same Product Code
79
Applicant Total
47
Review Days
23
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Basic Information
- Device Name
- VALVE, PEEP
- K Number
- K760230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5965
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Products
- Date Received
- July 14, 1976
- Decision Date
- August 6, 1976
- 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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Other Clearances by Ohio Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K841733 | OHIO WASTE GAS SCAVENGING RESERVOIR | Jul 11, 1984 | Substantially Equivalent |
| K842003 | OHIO WASTE GAS SCAVENGING INTERFACE | May 23, 1984 | Substantially Equivalent |
| K840356 | OHIO UNITROL II ANESTHESIA GAS MACHINE | Apr 20, 1984 | Substantially Equivalent |
| K841274 | BAG-TO-VENTILATOR SELECTOR VALVE | Apr 13, 1984 | Substantially Equivalent |
| K840967 | OHIO HEAT REFLECTING PATCH | Mar 23, 1984 | Substantially Equivalent |
| K840858 | OHIO 3300 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840857 | OHIO 3000 INFANT WARMER SYSTEM | Mar 23, 1984 | Substantially Equivalent |
| K840453 | MEDISHIELD PVM RESPIROMETER | Mar 2, 1984 | Substantially Equivalent |
| K840452 | PREMIUM DABM DISPOS. ANES. BREATH MASK | Feb 17, 1984 | Substantially Equivalent |
| K833335 | MODULUS II ANESTHESIA GAS MACHINE | Nov 14, 1983 | Substantially Equivalent |