510(k) K940245
K940245 is an FDA 510(k) premarket notification submitted by Evacu Technologies, Inc. for the device "EVACU-SLED". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1994
- Date Received
- January 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stretcher, Hand-Carried
- Device Class
- Class I
- Regulation Number
- 880.6900
- Review Panel
- HO
- Submission Type