510(k) K770015

NOSECLIP FOR RESP. CARE & PULMON. FUNC. by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code BXJ

K770015 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "NOSECLIP FOR RESP. CARE & PULMON. FUNC.". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code BXJ (Clip, Nose), a Class I device regulated under 21 CFR 868.6225. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1977
Date Received
January 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Nose
Device Class
Class I
Regulation Number
868.6225
Review Panel
AN
Submission Type