The following data is part of a premarket notification filed by Broadwest Corp. with the FDA for Podoscope.
| Device ID | K864499 |
| 510k Number | K864499 |
| Device Name: | PODOSCOPE |
| Classification | Transducer, Miniature Pressure |
| Applicant | BROADWEST CORP. 260 WEST BROADWAY New York, NY 10013 |
| Contact | Jack Donovan |
| Correspondent | Jack Donovan BROADWEST CORP. 260 WEST BROADWAY New York, NY 10013 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-14 |
| Decision Date | 1987-02-04 |