FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
OHMEDA 7900 ANESTHESIA VENTILATOR
K Number: K960964
·
Decision Sep 27, 1996
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
498
Applicant Total
120
Review Days
200
Basic Information
- Device Name
- OHMEDA 7900 ANESTHESIA VENTILATOR
- K Number
- K960964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- OHMEDA MEDICAL
- Date Received
- March 11, 1996
- Decision Date
- September 27, 1996
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBK), ordered by most recent decision date.
AVEA disposable expiratory filter/water trap (11790)
FDA 510(k)
FDA Class 2
·Anesthesiology
AF531 Oro-Nasal SE Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
731 Series Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
Ventoux VC2; Ventoux VC3
FDA 510(k)
FDA Class 2
·Anesthesiology
RESPOND(R) Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by OHMEDA MEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K123309 | GIRAFFE AND PANDA WARMERS | Feb 5, 2013 | Substantially Equivalent |
| K101788 | GIRAFFE OMNIBED | Jul 21, 2010 | Substantially Equivalent |
| K101778 | GIRAFFE INCUBATOR | Jul 21, 2010 | Substantially Equivalent |
| K090697 | MODIFICATION TO: GIRAFFE AND PANDA WARMER | Apr 16, 2009 | Substantially Equivalent |
| K072157 | MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Aug 27, 2007 | Substantially Equivalent |
| K070377 | GIRAFFE AND PANDA WARMER | Jul 11, 2007 | Substantially Equivalent |
| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K070247 | GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Apr 16, 2004 | Substantially Equivalent |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |