ALPHAMED GEMINI SENSOR, SNORING SENSOR

Ventilatory Effort Recorder

ALPHAMED, INC.

The following data is part of a premarket notification filed by Alphamed, Inc. with the FDA for Alphamed Gemini Sensor, Snoring Sensor.

Pre-market Notification Details

• Device ID: K990321
• 510k Number: K990321
• Device Name: ALPHAMED GEMINI SENSOR, SNORING SENSOR
• Classification: Ventilatory Effort Recorder
• Applicant: ALPHAMED, INC. 3989 CENTRAL AVE. NE SUITE 560 Minneapolis, MN 55421
• Contact: Peter Stase
• Correspondent: Peter Stase; ALPHAMED, INC. 3989 CENTRAL AVE. NE SUITE 560 Minneapolis, MN 55421
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-01
• Decision Date: 1999-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817377022487	K990321	000
00817377020902	K990321	000
00817377020919	K990321	000
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00817377021190	K990321	000
00817377021206	K990321	000
00817377022432	K990321	000