The following data is part of a premarket notification filed by Sarmed Srl with the FDA for Single Use Esophageal Manometey Catheters And Single Use Ano-rectal Manometry Catheters.
| Device ID | K062362 |
| 510k Number | K062362 |
| Device Name: | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS |
| Classification | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Applicant | SARMED SRL VIA DEGLI ARTIGIANI, 6 Medolla, IT 41036 |
| Contact | Antonio Rossetti |
| Correspondent | Antonio Rossetti SARMED SRL VIA DEGLI ARTIGIANI, 6 Medolla, IT 41036 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-14 |
| Decision Date | 2007-04-13 |
| Summary: | summary |