The following data is part of a premarket notification filed by Clinical Innovations, Llc with the FDA for Koala Toco.
| Device ID | K140163 |
| 510k Number | K140163 |
| Device Name: | KOALA TOCO |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | CLINICAL INNOVATIONS, LLC 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
| Contact | Joanne Bronikowski |
| Correspondent | Joanne Bronikowski CLINICAL INNOVATIONS, LLC 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814247020288 | K140163 | 000 |