The following data is part of a premarket notification filed by Memtec Corp. with the FDA for Model 950-12l Holter Recorder Without Analysis.
| Device ID | K102723 |
| 510k Number | K102723 |
| Device Name: | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | MEMTEC CORP. 68 STILES RD. UNIT D Salem, NH 03079 |
| Contact | Dennis Garboski |
| Correspondent | Dennis Garboski MEMTEC CORP. 68 STILES RD. UNIT D Salem, NH 03079 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2010-12-09 |
| Summary: | summary |