The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Model 118 Pulse Megason.
| Device ID | K800632 |
| 510k Number | K800632 |
| Device Name: | MODEL 118 PULSE MEGASON |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | BIRTCHER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-20 |
| Decision Date | 1980-05-02 |