The following data is part of a premarket notification filed by Remco Italia S.p.a. with the FDA for Click Holter.
| Device ID | K032276 |
| 510k Number | K032276 |
| Device Name: | CLICK HOLTER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | REMCO ITALIA S.P.A. VIA RIVOLTANA NUOVA 53 South Pedrino Di Vignate, Mi., IT 20060 |
| Contact | Luigi Bucchi |
| Correspondent | Luigi Bucchi REMCO ITALIA S.P.A. VIA RIVOLTANA NUOVA 53 South Pedrino Di Vignate, Mi., IT 20060 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-23 |
| Decision Date | 2003-08-27 |
| Summary: | summary |