The following data is part of a premarket notification filed by Micro Medical, Ltd. with the FDA for Pulmolife.
Device ID | K061283 |
510k Number | K061283 |
Device Name: | PULMOLIFE |
Classification | Spirometer, Diagnostic |
Applicant | MICRO MEDICAL, LTD. QUAYSIDE CHATHAM MARITIME Chatham, Kent, GB Me4 4qy |
Contact | Glen Hillsley |
Correspondent | Glen Hillsley MICRO MEDICAL, LTD. QUAYSIDE CHATHAM MARITIME Chatham, Kent, GB Me4 4qy |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-08 |
Decision Date | 2006-12-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
54250892905537 | K061283 | 000 |
54250892905520 | K061283 | 000 |
54250892905513 | K061283 | 000 |
54250892901577 | K061283 | 000 |
54250892901560 | K061283 | 000 |
54250892901553 | K061283 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PULMOLIFE 76645664 3232135 Live/Registered |
CAREFUSION U.K. 232 LIMITED 2005-08-26 |