510(k) K801250
K801250 is an FDA 510(k) premarket notification submitted by Medichanics, Inc. for the device "HYDRA TRED DC". The FDA issued a decision of Substantially Equivalent on June 17, 1980. The device falls under product code IOG (Treadmill, Mechanical), a Class I device regulated under 21 CFR 890.5370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1980
- Date Received
- May 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Treadmill, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type