SPACELABS MEDICAL MODEL 90481 EEG MODULE

Full-montage Standard Electroencephalograph

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Model 90481 Eeg Module.

Pre-market Notification Details

• Device ID: K932842
• 510k Number: K932842
• Device Name: SPACELABS MEDICAL MODEL 90481 EEG MODULE
• Classification: Full-montage Standard Electroencephalograph
• Applicant: SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514
• Contact: Raymond Gifford
• Correspondent: Raymond Gifford; SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-06-11
• Decision Date: 1994-03-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841522106279	K932842	000