The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for S9 Greenhills.
Device ID | K140279 |
510k Number | K140279 |
Device Name: | S9 GREENHILLS |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Contact | Jim Cassi |
Correspondent | Jim Cassi RESMED LTD. 9001 SPECTRUM CENTER BLVD. San Diego, CA 92123 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-03 |
Decision Date | 2014-07-31 |
Summary: | summary |