The following data is part of a premarket notification filed by Yeescope Pty. Ltd. with the FDA for Yeescope Laryngoscopes.
Device ID | K140951 |
510k Number | K140951 |
Device Name: | YEESCOPE LARYNGOSCOPES |
Classification | Laryngoscope, Rigid |
Applicant | YEESCOPE PTY. LTD. 10 BINNEY ROAD Kings Park, Nsw, AU 2148 |
Contact | Paul Dryden |
Correspondent | Paul Dryden YEESCOPE PTY. LTD. 10 BINNEY ROAD Kings Park, Nsw, AU 2148 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-14 |
Decision Date | 2014-11-10 |
Summary: | summary |