The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Metaneb 4 System.
Device ID | K151689 |
510k Number | K151689 |
Device Name: | MetaNeb 4 System |
Classification | Device, Positive Pressure Breathing, Intermittent |
Applicant | Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG 768923 |
Contact | Huifang Zhu |
Correspondent | Paul Dryden Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore, SG 768923 |
Product Code | NHJ |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-23 |
Decision Date | 2016-03-17 |
Summary: | summary |