The following data is part of a premarket notification filed by Hamilton Medical Ag with the FDA for Ventilair Ii Medical Air Compressor.
Device ID | K041781 |
510k Number | K041781 |
Device Name: | VENTILAIR II MEDICAL AIR COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | HAMILTON MEDICAL AG PO BOX 30008 Reno, NV 89502 |
Contact | J. David Thompson |
Correspondent | J. David Thompson HAMILTON MEDICAL AG PO BOX 30008 Reno, NV 89502 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-07-01 |
Decision Date | 2005-03-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630002800358 | K041781 | 000 |