The following data is part of a premarket notification filed by Broadwest Corp. with the FDA for Inox Dry Heat Sterilizer.
| Device ID | K851307 |
| 510k Number | K851307 |
| Device Name: | INOX DRY HEAT STERILIZER |
| Classification | Sterilizer, Dry Heat |
| 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 | KMH |
| CFR Regulation Number | 880.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-05-09 |