The following data is part of a premarket notification filed by Sanyo North America Corp. with the FDA for Sanyo Co2 Incubators, Models Nos. Mco-17ac, Mco-17aic, Mco-20aic,and Mc0-175m.
| Device ID | K013703 |
| 510k Number | K013703 |
| Device Name: | SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M |
| Classification | Accessory, Assisted Reproduction |
| Applicant | SANYO NORTH AMERICA CORP. 900 N. ARLINGTON HEIGHTS RD. SUITE 310 Tasca, IL 60143 -2844 |
| Contact | Sachi Kataoka |
| Correspondent | Sachi Kataoka SANYO NORTH AMERICA CORP. 900 N. ARLINGTON HEIGHTS RD. SUITE 310 Tasca, IL 60143 -2844 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2001-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987905300229 | K013703 | 000 |
| 04987905300212 | K013703 | 000 |
| 04987905300120 | K013703 | 000 |
| 04987905300113 | K013703 | 000 |
| 04987905300090 | K013703 | 000 |
| 04987905300076 | K013703 | 000 |
| 04987905300069 | K013703 | 000 |
| 04987905300045 | K013703 | 000 |