The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Biodynamics Model Bi-400 Body Composition Analyzer.
| Device ID | K881968 |
| 510k Number | K881968 |
| Device Name: | BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER |
| Classification | Plethysmograph, Impedance |
| Applicant | BIODYNAMICS CORP. 2405 140TH AVE. N.E., #101 Bellevue, WA 98005 |
| Contact | Edward M Rifkin |
| Correspondent | Edward M Rifkin BIODYNAMICS CORP. 2405 140TH AVE. N.E., #101 Bellevue, WA 98005 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-11 |
| Decision Date | 1988-07-28 |