510(k) K171936
K171936 is an FDA 510(k) premarket notification submitted by Peerbridge Health, Inc. for the device "Peerbridge Cor(TM) System". The FDA issued a decision of Substantially Equivalent on September 27, 2017. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Peerbridge Health, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2017
- Date Received
- June 28, 2017
- Clearance Type
- Traditional
- 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