The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Vb-1830/vb-1530, Video Bronchoscope.
Device ID | K934920 |
510k Number | K934920 |
Device Name: | VB-1830/VB-1530, VIDEO BRONCHOSCOPE |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
Contact | Paul Silva |
Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-15 |
Decision Date | 1994-01-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04961333224364 | K934920 | 000 |