The following data is part of a premarket notification filed by Hunan Accurate Bio-medical Technology Co., Ltd. with the FDA for Pulse Oximeter.
| Device ID | K141105 |
| 510k Number | K141105 |
| Device Name: | PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. M8-613, NO.8, LUTIAN RD. CHANGSHA NATIONAL HI-TECH INDUST DEVELOPMENT ZONE Changsha, Hunan, CN 410205 |
| Contact | Li Zhang |
| Correspondent | Li Zhang HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. M8-613, NO.8, LUTIAN RD. CHANGSHA NATIONAL HI-TECH INDUST DEVELOPMENT ZONE Changsha, Hunan, CN 410205 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-29 |
| Decision Date | 2014-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370393908017 | K141105 | 000 |
| 69273945555550 | K141105 | 000 |
| 69273945000814 | K141105 | 000 |
| 69273945000746 | K141105 | 000 |
| 69273945000500 | K141105 | 000 |
| 69273945000128 | K141105 | 000 |
| 69273945000050 | K141105 | 000 |
| 00860002249636 | K141105 | 000 |
| 00031262099952 | K141105 | 000 |
| 00031262099280 | K141105 | 000 |
| MHC18603203 | K141105 | 000 |
| 06927394500005 | K141105 | 000 |
| 06927394500012 | K141105 | 000 |
| 00810003751171 | K141105 | 000 |
| 00810003751164 | K141105 | 000 |
| 06927394555555 | K141105 | 000 |
| 06927394544443 | K141105 | 000 |
| 06927394500081 | K141105 | 000 |
| 06927394500074 | K141105 | 000 |
| 06927394500067 | K141105 | 000 |
| 06927394500050 | K141105 | 000 |
| 06927394500036 | K141105 | 000 |
| 06927394500029 | K141105 | 000 |
| MHC18603103 | K141105 | 000 |