510(k) K971749

EASYGO ASPIRATOR by Precision Medical, Inc. — Product Code BTA

K971749 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "EASYGO ASPIRATOR". The FDA issued a decision of Substantially Equivalent on April 1, 1998. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1998
Date Received
May 12, 1997
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