The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Pc-180 / Prince 180 Easy Ecg Monitor.
| Device ID | K073152 |
| 510k Number | K073152 |
| Device Name: | PC-180 / PRINCE 180 EASY ECG MONITOR |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD 2/F, BLOCK 3 NANYOU TIAN' AN INDUSTRY TOWN Shenzhen,gd, CN 518054 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2008-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980021396 | K073152 | 000 |
| 00817980021389 | K073152 | 000 |
| 06941900603066 | K073152 | 000 |