The following data is part of a premarket notification filed by Georgene Austria with the FDA for Aim Accuracy In Marking System.
| Device ID | K053463 |
| 510k Number | K053463 |
| Device Name: | AIM ACCURACY IN MARKING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GEORGENE AUSTRIA 5755 VALERIE AVENUE Woodland Hills, CA 91367 |
| Contact | Georgene Austria |
| Correspondent | Georgene Austria GEORGENE AUSTRIA 5755 VALERIE AVENUE Woodland Hills, CA 91367 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003024102 | K053463 | 000 |