510(k) K201248
K201248 is an FDA 510(k) premarket notification submitted by Vapocoolshot, Inc. for the device "Syringe Holder accessory". The FDA issued a decision of Substantially Equivalent on August 12, 2020. The device falls under product code MLY (Vapocoolant Device), a Class U device. Vapocoolshot, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2020
- Date Received
- May 11, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vapocoolant Device
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type