FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SARNS AIR DETECTION SYSTEM
K Number: K935977
·
Decision Feb 4, 1994
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
13
Applicant Total
76
Review Days
53
Basic Information
- Device Name
- SARNS AIR DETECTION SYSTEM
- K Number
- K935977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4205
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M HEALTH CARE, SARNS
- Date Received
- December 13, 1993
- Decision Date
- February 4, 1994
- Product Code
- KRL
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KRL | Detector, Bubble, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by 3M HEALTH CARE, SARNS
| K Number | Device Name | ||
|---|---|---|---|
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | Jun 4, 1996 | Substantially Equivalent |
| K953901 | SARNS 800 ROLLER PUMP | Apr 19, 1996 | Substantially Equivalent |
| K950739 | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM | Nov 17, 1995 | Substantially Equivalent |
| K941653 | SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION | Aug 24, 1994 | Substantially Equivalent |
| K941654 | SARNS FILTERED VENOUS RESERVIOR MODIFICATION | Jul 26, 1994 | Substantially Equivalent |
| K940651 | SARNS ULTRASONIC AIR SENSOR | May 24, 1994 | Substantially Equivalent |
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK | Feb 24, 1994 | Substantially Equivalent |
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA | Feb 22, 1994 | Substantially Equivalent |
| K915547 | SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT | Sep 9, 1993 | Substantially Equivalent |
| K925076 | SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R. | Jun 7, 1993 | Substantially Equivalent |