The following data is part of a premarket notification filed by Amira Medical, Inc. with the FDA for Amira Medical Atlast Blood Glucose Monitoring System.
| Device ID | K982076 |
| 510k Number | K982076 |
| Device Name: | AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | AMIRA MEDICAL, INC. 4742 SCOTTS VALLEY DR. Scotts Valley, CA 95066 |
| Contact | David A Hasker |
| Correspondent | David A Hasker 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 | 1998-06-12 |
| Decision Date | 1998-12-10 |
| Summary: | summary |