The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap Iii St-a.
Device ID | K033276 |
510k Number | K033276 |
Device Name: | VPAP III ST-A |
Classification | Ventilator, Continuous, Non-life-supporting |
Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Contact | David D'cruz |
Correspondent | David D'cruz RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Product Code | MNS |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-10 |
Decision Date | 2004-06-07 |
Summary: | summary |