The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Modified Schneider-shiley Pressure Manometer.
Device ID | K875322 |
510k Number | K875322 |
Device Name: | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER |
Classification | Manometer, Blood-pressure, Venous |
Applicant | SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
Contact | Ann Morrissey |
Correspondent | Ann Morrissey SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
Product Code | KRK |
CFR Regulation Number | 870.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-29 |
Decision Date | 1988-03-28 |