The following data is part of a premarket notification filed by Nautilus Environmedical Systems, Inc. with the FDA for Sechrist Ventilator/nautilus Chamber Combination.
Device ID | K850563 |
510k Number | K850563 |
Device Name: | SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION |
Classification | Chamber, Hyperbaric |
Applicant | NAUTILUS ENVIRONMEDICAL SYSTEMS, INC. JOHN S. EGBERT 6960 TEXAS COMMERCE TOWER Houston, TX 77002 |
Contact | & Egbe |
Correspondent | & Egbe NAUTILUS ENVIRONMEDICAL SYSTEMS, INC. JOHN S. EGBERT 6960 TEXAS COMMERCE TOWER Houston, TX 77002 |
Product Code | CBF |
CFR Regulation Number | 868.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-12 |
Decision Date | 1985-03-12 |