510(k) K802165

SHERWOOD VENTILATORY MUSCLE TRAINER by Sherwood Medical Co. — Product Code BYW

K802165 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "SHERWOOD VENTILATORY MUSCLE TRAINER". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code BYW (Device, Rebreathing), a Class I device regulated under 21 CFR 868.5675. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
September 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Rebreathing
Device Class
Class I
Regulation Number
868.5675
Review Panel
AN
Submission Type