The following data is part of a premarket notification filed by Jedmed Instrument Company with the FDA for Orl Video Nasopharyngo-larngoscope.
Device ID | K150248 |
510k Number | K150248 |
Device Name: | ORL Video NasoPharyngo-Larngoscope |
Classification | Laryngoscope, Nasopharyngoscope |
Applicant | JEDMED INSTRUMENT COMPANY 5416 JEDMED COURT St. Louis, MO 63129 |
Contact | Craig Parks |
Correspondent | Craig Parks JEDMED INSTRUMENT COMPANY 5416 JEDMED COURT St. Louis, MO 63129 |
Product Code | EQN |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-03 |
Decision Date | 2015-07-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B809M2052203101010 | K150248 | 000 |
B809M205240310101 | K150248 | 000 |
B809M205220310101 | K150248 | 000 |
B809M105220300700 | K150248 | 000 |