The following data is part of a premarket notification filed by Cardio Design Pty. Ltd. with the FDA for Peritron.
| Device ID | K945611 |
| 510k Number | K945611 |
| Device Name: | PERITRON |
| Classification | Perineometer |
| Applicant | CARDIO DESIGN PTY. LTD. 7089 CROWNE OAK RD. Eden Prairie, MN 55344 |
| Contact | Stephan Norsted |
| Correspondent | Stephan Norsted CARDIO DESIGN PTY. LTD. 7089 CROWNE OAK RD. Eden Prairie, MN 55344 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-15 |
| Decision Date | 1996-02-08 |