510(k) K110525
K110525 is an FDA 510(k) premarket notification submitted by Vitalograph (Ireland) , Ltd. for the device "VITALOGRAPH MODEL 7100 - VITALOJAK". The FDA issued a decision of Substantially Equivalent on Nov 23, 2011. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Vitalograph (Ireland) , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 23, 2011
- Date Received
- Feb 23, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type