510(k) K972528
K972528 is an FDA 510(k) premarket notification submitted by Dyna Corp. for the device "DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759)". The FDA issued a decision of Substantially Equivalent on July 28, 1997. The device falls under product code FPO (Stretcher, Wheeled), a Class II device regulated under 21 CFR 880.6910. Dyna Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1997
- Date Received
- July 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stretcher, Wheeled
- Device Class
- Class II
- Regulation Number
- 880.6910
- Review Panel
- HO
- Submission Type