The following data is part of a premarket notification filed by Bauerfeind Ag with the FDA for Bodytronic 200.
| Device ID | K123921 |
| 510k Number | K123921 |
| Device Name: | BODYTRONIC 200 |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | BAUERFEIND AG TRIEBESER STRASSE 16 Zeulenroda-triebes, DE 07937 |
| Contact | Ines Exner |
| Correspondent | Ines Exner BAUERFEIND AG TRIEBESER STRASSE 16 Zeulenroda-triebes, DE 07937 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-04-26 |
| Summary: | summary |