The following data is part of a premarket notification filed by Venner Medical (singapore) Pte Ltd with the FDA for Apa Oxy Blade.
| Device ID | K191602 |
| 510k Number | K191602 |
| Device Name: | APA Oxy Blade |
| Classification | Laryngoscope, Rigid |
| Applicant | Venner Medical (Singapore) Pte Ltd 35 Joo Koon Circle Singapore, SG 629110 |
| Contact | Adrian P. Waterton |
| Correspondent | Christine Brauer Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-08-02 |