The following data is part of a premarket notification filed by Chongqing Psk Sci-tech Development Co., Ltd with the FDA for External Counterpulsation Device With Sp02 Mornitoring.
| Device ID | K130439 |
| 510k Number | K130439 |
| Device Name: | EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING |
| Classification | Device, Counter-pulsating, External |
| Applicant | CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD 05C. FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN, CHINA Shenzhen, Guangdong, CN 518000 |
| Contact | Field Fu |
| Correspondent | Field Fu CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD 05C. FUHAI KANGLE BUILDING NANSHAN DISTRICT SHENZHEN, CHINA Shenzhen, Guangdong, CN 518000 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971379470029 | K130439 | 000 |
| 06971379470012 | K130439 | 000 |