The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap Iii St-a.
Device ID | K093731 |
510k Number | K093731 |
Device Name: | VPAP III ST-A |
Classification | Ventilator, Continuous, Non-life-supporting |
Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Contact | David D'curz |
Correspondent | David D'curz RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Product Code | MNS |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-03 |
Decision Date | 2010-03-22 |
Summary: | summary |