The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Bronchofiberscope #fb-19e.
Device ID | K822844 |
510k Number | K822844 |
Device Name: | PENTAX BRONCHOFIBERSCOPE #FB-19E |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-23 |
Decision Date | 1982-10-26 |