510(k) K140095
K140095 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "PRIME ZOOM STRETCHER". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. Stryker Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2014
- Date Received
- January 14, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stretcher, Wheeled, Powered
- Device Class
- Class II
- Regulation Number
- 890.3690
- Review Panel
- PM
- Submission Type