The following data is part of a premarket notification filed by Micromedical Industries, Ltd. with the FDA for Modification To: Pocketview Ecg Software.
| Device ID | K013311 |
| 510k Number | K013311 |
| Device Name: | MODIFICATION TO: POCKETVIEW ECG SOFTWARE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MICROMEDICAL INDUSTRIES, LTD. 11 TECHNOLOGY DR. Labrador Queensland, AU 4215 |
| Contact | Stephen Cresswell |
| Correspondent | Stephen Cresswell MICROMEDICAL INDUSTRIES, LTD. 11 TECHNOLOGY DR. Labrador Queensland, AU 4215 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-04 |
| Decision Date | 2002-01-03 |
| Summary: | summary |