510(k) K920526
K920526 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER DYNAMIC MATTRESS SYSTEM (DMS) MODEL #2500". The FDA issued a decision of Substantially Equivalent on September 21, 1992. The device falls under product code IOG (Treadmill, Mechanical), a Class I device regulated under 21 CFR 890.5370. Stryker Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1992
- Date Received
- February 4, 1992
- 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