The following data is part of a premarket notification filed by Shanghai Lishen Scientific Equipment Co., Ltd with the FDA for Heal Force Co2 Incubator.
| Device ID | K101988 |
| 510k Number | K101988 |
| Device Name: | HEAL FORCE CO2 INCUBATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charles Mack |
| Correspondent | Charles Mack SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-14 |
| Decision Date | 2011-02-08 |
| Summary: | summary |