510(k) K780037

EXERCISER, RESP., DEEP BREATHING by Medical Technologies of Georgia — Product Code BWF

K780037 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "EXERCISER, RESP., DEEP BREATHING". The FDA issued a decision of Substantially Equivalent on February 24, 1978. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Medical Technologies of Georgia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1978
Date Received
January 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type