The following data is part of a premarket notification filed by Diagnostic Monitoring Software with the FDA for Dms 300-7.
Device ID | K062007 |
510k Number | K062007 |
Device Name: | DMS 300-7 |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | DIAGNOSTIC MONITORING SOFTWARE 292 KINGSBURY, 32B P.O. BOX 3109 Stateline, NV 89449 |
Contact | William Parsons |
Correspondent | William Parsons DIAGNOSTIC MONITORING SOFTWARE 292 KINGSBURY, 32B P.O. BOX 3109 Stateline, NV 89449 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-17 |
Decision Date | 2006-08-16 |
Summary: | summary |