510(k) K202456
K202456 is an FDA 510(k) premarket notification submitted by Global Instrumentation, LLC for the device "M5 Recorder". The FDA issued a decision of Substantially Equivalent on December 29, 2020. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Global Instrumentation, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2020
- Date Received
- August 27, 2020
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type