The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Cybermedic Cm-810 Body Plethysmograph.
| Device ID | K851197 |
| 510k Number | K851197 |
| Device Name: | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH |
| Classification | Plethysmograph, Volume |
| Applicant | CYBERMEDIC, INC. P.O. BOX 3468 Boulder, CO 80307 |
| Contact | Susan M Weiss |
| Correspondent | Susan M Weiss CYBERMEDIC, INC. P.O. BOX 3468 Boulder, CO 80307 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-07-08 |