The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap Iii.
Device ID | K030843 |
510k Number | K030843 |
Device Name: | VPAP III |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Contact | Roger Kotter |
Correspondent | Roger Kotter RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-17 |
Decision Date | 2003-08-15 |
Summary: | summary |