510(k) K193273
K193273 is an FDA 510(k) premarket notification submitted by Promisemed Hangzhou Meditech Co., Ltd. for the device "Insulin Syringe". The FDA issued a decision of Substantially Equivalent on Jan 5, 2021. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Promisemed Hangzhou Meditech Co., Ltd. has 35 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 2021
- Date Received
- Nov 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)