The following data is part of a premarket notification filed by Cetro America with the FDA for Fetal Ultrasound And Tocodynamometer Transducers.
| Device ID | K050826 |
| 510k Number | K050826 |
| Device Name: | FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS |
| Classification | System, Monitoring, Perinatal |
| Applicant | CETRO AMERICA 925 SHERMAN AVENUE Hamden, CT 06514 |
| Contact | Maya Cianciolo |
| Correspondent | Maya Cianciolo CETRO AMERICA 925 SHERMAN AVENUE Hamden, CT 06514 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2006-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852519007243 | K050826 | 000 |
| 00852519007038 | K050826 | 000 |
| 00852519007014 | K050826 | 000 |
| 00852519007007 | K050826 | 000 |
| 00852519007397 | K050826 | 000 |
| 00852519007380 | K050826 | 000 |
| 00852519007373 | K050826 | 000 |
| 00852519007366 | K050826 | 000 |
| 00852519007359 | K050826 | 000 |
| 00852519007342 | K050826 | 000 |
| 00852519007335 | K050826 | 000 |
| 00852519007328 | K050826 | 000 |
| 00852519007311 | K050826 | 000 |
| 00852519007304 | K050826 | 000 |
| 00852519007298 | K050826 | 000 |
| 00852519007281 | K050826 | 000 |
| 00852519007274 | K050826 | 000 |
| 00852519007267 | K050826 | 000 |
| 00852519007045 | K050826 | 000 |
| 00852519007052 | K050826 | 000 |
| 00852519007069 | K050826 | 000 |
| 00852519007236 | K050826 | 000 |
| 00852519007229 | K050826 | 000 |
| 00852519007212 | K050826 | 000 |
| 00852519007205 | K050826 | 000 |
| 00852519007199 | K050826 | 000 |
| 00852519007182 | K050826 | 000 |
| 00852519007175 | K050826 | 000 |
| 00852519007168 | K050826 | 000 |
| 00852519007151 | K050826 | 000 |
| 00852519007144 | K050826 | 000 |
| 00852519007137 | K050826 | 000 |
| 00852519007120 | K050826 | 000 |
| 00852519007113 | K050826 | 000 |
| 00852519007106 | K050826 | 000 |
| 00852519007090 | K050826 | 000 |
| 00852519007083 | K050826 | 000 |
| 00852519007076 | K050826 | 000 |
| 00852519007250 | K050826 | 000 |