The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd with the FDA for Ds Torsocardiac 1.5t, Ds Msk S 1.5t, Ds Msk M 1.5t.
Device ID | K212864 |
510k Number | K212864 |
Device Name: | DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
Contact | Seaman Shao |
Correspondent | Seaman Shao Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-08 |
Decision Date | 2021-12-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838096837 | K212864 | 000 |
00884838096820 | K212864 | 000 |
00884838096813 | K212864 | 000 |