The following data is part of a premarket notification filed by Cardio Design Pty. Ltd. with the FDA for Peritron Perineometer Model 9300v Or 9300a.
| Device ID | K983052 |
| 510k Number | K983052 |
| Device Name: | PERITRON PERINEOMETER MODEL 9300V OR 9300A |
| Classification | Perineometer |
| Applicant | CARDIO DESIGN PTY. LTD. P.O. BOX 6407 BHBC Baulkham Hills Nsw, AU 2153 |
| Contact | Neville Motley |
| Correspondent | Neville Motley CARDIO DESIGN PTY. LTD. P.O. BOX 6407 BHBC Baulkham Hills Nsw, AU 2153 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-01 |
| Decision Date | 1998-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627825006361 | K983052 | 000 |