The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Masterscreen & Oxycon Cpx.
Device ID | K072323 |
510k Number | K072323 |
Device Name: | MASTERSCREEN & OXYCON CPX |
Classification | Calculator, Pulmonary Function Data |
Applicant | VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Contact | Yvette Lloyd |
Correspondent | Yvette Lloyd VIASYS HEALTHCARE GMBH 22745 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
Product Code | BZC |
CFR Regulation Number | 868.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-20 |
Decision Date | 2007-10-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04250892905051 | K072323 | 000 |
14250892906529 | K072323 | 000 |
14250892906536 | K072323 | 000 |
14250892906659 | K072323 | 000 |
14250892903672 | K072323 | 000 |
14250892903689 | K072323 | 000 |
14250892904006 | K072323 | 000 |
14250892902163 | K072323 | 000 |
14250892902279 | K072323 | 000 |
14250892902286 | K072323 | 000 |
14250892903986 | K072323 | 000 |
14250892903993 | K072323 | 000 |
04250892902715 | K072323 | 000 |
04250892902722 | K072323 | 000 |
04250892902739 | K072323 | 000 |
04250892902753 | K072323 | 000 |
04250892905037 | K072323 | 000 |
04250892905044 | K072323 | 000 |
14250892906499 | K072323 | 000 |