The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Infant Incubator.
| Device ID | K132543 |
| 510k Number | K132543 |
| Device Name: | INFANT INCUBATOR |
| Classification | Incubator, Neonatal |
| Applicant | BISTOS CO., LTD. 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi BISTOS CO., LTD. 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-13 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887529000134 | K132543 | 000 |