510(k) K070204

LINK TO ACUITY CLINICIAN NOTIFIER by Welch Allyn Protocol, Inc. — Product Code MSX

K070204 is an FDA 510(k) premarket notification submitted by Welch Allyn Protocol, Inc. for the device "LINK TO ACUITY CLINICIAN NOTIFIER". The FDA issued a decision of Substantially Equivalent on March 23, 2007. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Welch Allyn Protocol, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2007
Date Received
January 22, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type