510(k) K213255
K213255 is an FDA 510(k) premarket notification submitted by Flashback Technologies, Inc. for the device "CipherOx CRI Tablet". The FDA issued a decision of Substantially Equivalent on June 17, 2022. The device falls under product code PPW (Adjunctive Cardiovascular Status Indicator), a Class II device regulated under 21 CFR 870.2200. Flashback Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2022
- Date Received
- September 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Cardiovascular Status Indicator
- Device Class
- Class II
- Regulation Number
- 870.2200
- Review Panel
- CV
- Submission Type
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.