The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Airway Pressure Monitor Model 600.
Device ID | K861330 |
510k Number | K861330 |
Device Name: | SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 |
Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
Contact | Sandra L Davis |
Correspondent | Sandra L Davis SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
Product Code | CAP |
CFR Regulation Number | 868.2600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-09 |
Decision Date | 1986-04-11 |