510(k) K073152
K073152 is an FDA 510(k) premarket notification submitted by Shenzhen Creative Industry Co., Ltd. for the device "PC-180 / PRINCE 180 EASY ECG MONITOR". The FDA issued a decision of Substantially Equivalent on Jan 10, 2008. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Shenzhen Creative Industry Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2008
- Date Received
- Nov 8, 2007
- 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
- 510(k)