The following data is part of a premarket notification filed by Pti with the FDA for Megapulse Ii.
| Device ID | K973732 |
| 510k Number | K973732 |
| Device Name: | MEGAPULSE II |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | PTI 6700 SW TOPEKA BLVD. FORBES FIELD, BLDG. 140 Topeka, KS 66619 |
| Contact | Chris C Astel |
| Correspondent | Chris C Astel PTI 6700 SW TOPEKA BLVD. FORBES FIELD, BLDG. 140 Topeka, KS 66619 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1998-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858703006078 | K973732 | 000 |