FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OXYGEN & RESUSCITATION (HOPE II MODEL)
K Number: K760101
·
Decision Jul 15, 1976
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
47
Review Days
22
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Basic Information
- Device Name
- OXYGEN & RESUSCITATION (HOPE II MODEL)
- K Number
- K760101
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Ohio Medical Products
- Date Received
- June 23, 1976
- Decision Date
- July 15, 1976
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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|---|---|---|---|
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| 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 |