TCM400
FDA 510(k) clearance K001866 · decided 2000-12-07
Clearance details
- K-number
- K001866
- Device name
- TCM400
- Applicant
- Radiometer Medical A/S
- Decision
- Substantially Equivalent
- Date received
- 2000-06-20
- Decision date
- 2000-12-07
- Days to decision
- 170 days
- Clearance type
- Special
- Product code
- LPP
- Device class
- 2
- Regulation number
- 868.2500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiometer Medical A/S
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 |
|---|---|---|
| HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275 (K885079) | Mennen Medical, Inc. | 1989-02-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, recall (Z-1930-2013) | Radiometer America Inc | 2013-08-08 |
| D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Moni recall (Z-1436-06) | Radiometer America Inc | 2006-08-31 |