The following data is part of a premarket notification filed by Epm Development Systems Corp. with the FDA for Snoring Sensor.
Device ID | K941759 |
510k Number | K941759 |
Device Name: | SNORING SENSOR |
Classification | Monitor, Breathing Frequency |
Applicant | EPM DEVELOPMENT SYSTEMS CORP. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112 |
Contact | Stephen A Burton |
Correspondent | Stephen A Burton EPM DEVELOPMENT SYSTEMS CORP. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-10 |
Decision Date | 1994-11-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05707480106479 | K941759 | 000 |
00840067103340 | K941759 | 000 |
00840067103357 | K941759 | 000 |
00840067103364 | K941759 | 000 |
00840067103371 | K941759 | 000 |
00840067103432 | K941759 | 000 |
05707480042418 | K941759 | 000 |
05707480042425 | K941759 | 000 |
05707480042456 | K941759 | 000 |
05707480042463 | K941759 | 000 |
05707480106462 | K941759 | 000 |
00840067103333 | K941759 | 000 |