The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Ergo-flex Laryngo-nasopharyngoscope Ef-n And Ef-n Slim.
| Device ID | K132039 |
| 510k Number | K132039 |
| Device Name: | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM |
| Classification | Laryngoscope, Nasopharyngoscope |
| Applicant | JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Contact | Craig Parks |
| Correspondent | Craig Parks JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Product Code | EQN |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2014-02-21 |
| Summary: | summary |