The following data is part of a premarket notification filed by Biodex Medical Systems, Inc. with the FDA for Atomlab 400 And Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 And -336.
| Device ID | K090296 |
| 510k Number | K090296 |
| Device Name: | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | BIODEX MEDICAL SYSTEMS, INC. 20 RAMSAY RD. Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00718175003350 | K090296 | 000 |
| 00718175003329 | K090296 | 000 |
| 00718175003305 | K090296 | 000 |
| 00718175003343 | K090296 | 000 |