FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CARDISUNY, 501BX
K Number: K900849
·
Decision Apr 4, 1990
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- CARDISUNY, 501BX
- K Number
- K900849
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Graham-Field, Inc.
- Date Received
- February 22, 1990
- Decision Date
- April 4, 1990
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
Other Clearances by Graham-Field, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970035 | JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 | Apr 1, 1997 | Substantially Equivalent |
| K961857 | LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 | Jul 3, 1996 | Substantially Equivalent |
| K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED | Mar 1, 1994 | Substantially Equivalent |
| K904904 | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION | Mar 19, 1991 | Substantially Equivalent |
| K901947 | CARDISUNY 501AB | Jul 17, 1990 | Substantially Equivalent |
| K901948 | CARDISUNY 501BIII | Jul 17, 1990 | Substantially Equivalent |
| K883224 | UNNA BOOT DRESSING W/CALAMINE | Jan 5, 1989 | Substantially Equivalent for Some Indications |