The following data is part of a premarket notification filed by Amira Medical, Inc. with the FDA for Atlast Data Management Software (dms).
| Device ID | K010605 |
| 510k Number | K010605 |
| Device Name: | ATLAST DATA MANAGEMENT SOFTWARE (DMS) |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMIRA MEDICAL, INC. 4742 SCOTTS VALLEY DR. Scotts Valley, CA 95066 |
| Contact | Nina Peled |
| Correspondent | Nina Peled AMIRA MEDICAL, INC. 4742 SCOTTS VALLEY DR. Scotts Valley, CA 95066 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-28 |
| Decision Date | 2001-05-07 |