The following data is part of a premarket notification filed by Huntleigh Healthcare with the FDA for Medilog Darwin Holter Analysis.
| Device ID | K053369 |
| 510k Number | K053369 |
| Device Name: | MEDILOG DARWIN HOLTER ANALYSIS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | HUNTLEIGH HEALTHCARE LION HOUSE; ORIENTAL ROAD WORKING Surrey, GB Gu22 8 Ap |
| Contact | James Pardey |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2005-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613365003758 | K053369 | 000 |