510(k) K841399

BRONCHOSCOPE SUCTION UNIT by Keymed, Inc. — Product Code BTA

K841399 is an FDA 510(k) premarket notification submitted by Keymed, Inc. for the device "BRONCHOSCOPE SUCTION UNIT". The FDA issued a decision of Substantially Equivalent on July 18, 1984. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Keymed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1984
Date Received
April 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type