510(k) K970116

Device: ESG-1 ELECTROSONOGRAM (ESG-1)
Applicant: MYO-TRONICS, INC.
510(k) number: K970116
Product code: NFQ
Decision: Substantially Equivalent (SESE)
Decision date: 1997-04-02
Date received: 1997-01-13
Regulation: 872.2050
Classification name: Device, Dental Sonography, For Monitoring Jaw Sounds
Medical specialty: Dental
Review panel: Dental
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: FRAY ADIB
Address: 15425 - 33rd Ave. S. Tukwila WA US 98188 98188

FDA Registration Numbers#

2183552
3014732
3009171220
3005418651
1316408

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
D79209830	K7 ESG-2 Electrosonograph	MYOTRONICS NOROMED, INC	2016-08-18

Other 510(k) Records For Product Code NFQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K905657	SONOPAK/QS, SONOPAK	Bioresearch	1991-05-15
K905449	ELECTROSONOGRAM ESG-1	Myo-Tronics, Inc.	1991-04-26
K862286	ARTHROPHONOMETER	Arthrotek, Inc.	1987-01-07

Legacy Summary#

summary

FDA Review#

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