EDAC QUANTIFIER
FDA 510(k) clearance K071231 · decided 2007-05-17
Clearance details
- K-number
- K071231
- Device name
- EDAC QUANTIFIER
- Applicant
- Luna Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-03
- Decision date
- 2007-05-17
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KRL
- Device class
- 2
- Regulation number
- 870.4205
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Blacksburg, VA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (K103469) | Sorin Group Deutschland GmbH | 2011-01-18 |
| CAPIOX BUBBLE TRAP WITH X-COATING (K090698) | Terumo Cardiovascular Systems | 2009-06-08 |
| AUTOMATIC TUBING CLAMP SYSTEM (ATC) (K961364) | Rocky Mountain Research, Inc. | 1996-10-31 |
| ELS AUTOMATIC TUBING CLAMP SYSTEM (K961598) | Rocky Mountain Research, Inc. | 1996-10-29 |
| SARNS ULTRASONIC AIR SENSOR (K940651) | 3M Health Care, Sarns | 1994-05-24 |
| SARNS AIR DETECTION SYSTEM (K935977) | 3M Health Care, Sarns | 1994-02-04 |
| STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (K925661) | Sorin Biomedica, Fiat, USA, Inc. | 1993-05-18 |
| STOCKERT 1/4 BUBBLE SENSOR (K925541) | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-02 |
| CAPIOX(R) BUBBLE TRAP (K911632) | Terumo Medical Corp. | 1991-07-09 |
| CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (K864619) | Shiley, Inc. | 1987-02-03 |
| COBE ACCESSORY INTERFACE MODULE (AIM) (K861860) | Cobe Laboratories, Inc. | 1986-07-18 |
| COBE AEPS (K842054) | Cobe Laboratories, Inc. | 1984-08-02 |
Recalls involving this device
No recalls on record reference this clearance.