The following data is part of a premarket notification filed by Astral Medical Systems with the FDA for Apollo Densitometer.
| Device ID | K853734 |
| 510k Number | K853734 |
| Device Name: | APOLLO DENSITOMETER |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | ASTRAL MEDICAL SYSTEMS 2861 PULLMAN ST. Santa Ana, CA 92705 |
| Contact | Keith S Fairchild |
| Correspondent | Keith S Fairchild ASTRAL MEDICAL SYSTEMS 2861 PULLMAN ST. Santa Ana, CA 92705 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1985-09-25 |