The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Easynet Oximeter Module.
Device ID | K061706 |
510k Number | K061706 |
Device Name: | CADWELL EASYNET OXIMETER MODULE |
Classification | Oximeter |
Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Contact | Chris Bolkan |
Correspondent | Chris Bolkan CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
Product Code | DQA |
CFR Regulation Number | 870.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-16 |
Decision Date | 2007-03-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840067100615 | K061706 | 000 |
00840067100493 | K061706 | 000 |
00840067103951 | K061706 | 000 |