510(k) K802165
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