CRIT-LINE MONITOR III TQA (CLM TQA)
FDA 510(k) clearance K011741 · decided 2002-07-23
Clearance details
- K-number
- K011741
- Device name
- CRIT-LINE MONITOR III TQA (CLM TQA)
- Applicant
- Hemametrics
- Decision
- Substantially Equivalent
- Date received
- 2001-06-05
- Decision date
- 2002-07-23
- Days to decision
- 413 days
- Clearance type
- Traditional
- Product code
- FIL
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kaysville, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hemametrics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPS 550-IPS (INTEGRATED PATIENT STATION) (K901038) | Baxter Healthcare Corp | 1990-04-19 |
| FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (K890329) | Fresenius USA, Inc. | 1989-05-11 |
| REPGREEN ULTRAFILTRATION MONITOR (K790824) | Cyberex Corp. | 1979-06-27 |
| ULTRAFILTRATION SCALE (K781633) | Extracorporeal Medical Specialities, Inc. | 1978-12-07 |
| ULTRAFILTRATION MONITOR 5M9034 (K771875) | Travenol Laboratories, S.A. | 1977-11-30 |
| AK-10 (K771227) | Gambro, Inc. | 1977-08-02 |
| NEGATIVE PRESSURE ADAPTER 5M1350 (K770137) | Travenol Laboratories, S.A. | 1977-02-01 |
Recalls involving this device
No recalls on record reference this clearance.