The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jedmed Spectrum Ent Cabinet.
| Device ID | K953457 |
| 510k Number | K953457 |
| Device Name: | JEDMED SPECTRUM ENT CABINET |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Contact | Craig R Parks |
| Correspondent | Craig R Parks JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-21 |
| Decision Date | 1995-08-11 |