The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Pc-60, Non-invasivepulse Oximeter.
| Device ID | K063641 |
| 510k Number | K063641 |
| Device Name: | PC-60, NON-INVASIVEPULSE OXIMETER |
| Classification | Oximeter |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD 340 SHADY GROVE RD Flintville, TN 37335 |
| Contact | Mack Charles |
| Correspondent | Mack Charles SHENZHEN CREATIVE INDUSTRY CO., LTD 340 SHADY GROVE RD Flintville, TN 37335 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-07 |
| Decision Date | 2007-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817980021457 | K063641 | 000 |
| 06941900603233 | K063641 | 000 |
| 06941900603202 | K063641 | 000 |
| 06941900603165 | K063641 | 000 |
| 06941900603110 | K063641 | 000 |
| 06941900603035 | K063641 | 000 |
| 06941900603028 | K063641 | 000 |
| 06941900600089 | K063641 | 000 |
| M368020202 | K063641 | 000 |
| 00850020077052 | K063641 | 000 |
| M368JB020071 | K063641 | 000 |
| 06941900603011 | K063641 | 000 |
| 06941900604407 | K063641 | 000 |
| 00850033167160 | K063641 | 000 |
| 00850033167153 | K063641 | 000 |
| 06941900603257 | K063641 | 000 |
| 06941900603264 | K063641 | 000 |
| 06941900603349 | K063641 | 000 |
| 00817980021440 | K063641 | 000 |
| 00817980021433 | K063641 | 000 |
| 00817980021426 | K063641 | 000 |
| 00817980021419 | K063641 | 000 |
| 00817980021402 | K063641 | 000 |
| 00869667000453 | K063641 | 000 |
| 00869667000446 | K063641 | 000 |
| 00869667000439 | K063641 | 000 |
| 00869667000422 | K063641 | 000 |
| 00869667000415 | K063641 | 000 |
| 00869667000408 | K063641 | 000 |
| 00845821026507 | K063641 | 000 |
| 00845821022561 | K063641 | 000 |
| 00845821012401 | K063641 | 000 |
| 00850033167146 | K063641 | 000 |