The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Tego, Model D1000.
| Device ID | K053106 |
| 510k Number | K053106 |
| Device Name: | TEGO, MODEL D1000 |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Dale Fairchild |
| Correspondent | Dale Fairchild ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-04 |
| Decision Date | 2006-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619069213 | K053106 | 000 |
| 10840619026056 | K053106 | 000 |