The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Link To Acuity Clinician Notifier.
Device ID | K070204 |
510k Number | K070204 |
Device Name: | LINK TO ACUITY CLINICIAN NOTIFIER |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
Contact | Jeffrey Wagner |
Correspondent | Jeffrey Wagner WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-22 |
Decision Date | 2007-03-23 |
Summary: | summary |