The following data is part of a premarket notification filed by Norland Medical Systems, Inc. with the FDA for Apollo Multi-racial Reference Population.
| Device ID | K993337 |
| 510k Number | K993337 |
| Device Name: | APOLLO MULTI-RACIAL REFERENCE POPULATION |
| Classification | Densitometer, Bone |
| Applicant | NORLAND MEDICAL SYSTEMS, INC. W-6340 HACKBARTH RD. Fort Atkinson, WI 53538 -8999 |
| Contact | Terry Schwalenberg |
| Correspondent | John Monahan NORLAND MEDICAL SYSTEMS, INC. 31 Gordan Road Piscataway, NJ 08854 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 2000-05-16 |
| Summary: | summary |