PIEZON 150

Scaler, Ultrasonic

E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Piezon 150.

Pre-market Notification Details

• Device ID: K132443
• 510k Number: K132443
• Device Name: PIEZON 150
• Classification: Scaler, Ultrasonic
• Applicant: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough, MA 01752
• Contact: Cynthia Nolte
• Correspondent: Cynthia Nolte; E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 62 FOREST ST., STE 300 Marlborough, MA 01752
• Product Code: ELC
• CFR Regulation Number: 872.4850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-06
• Decision Date: 2013-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613353172411	K132443	000
07613353190941	K132443	000
07613353190934	K132443	000
07613353190927	K132443	000
07613353190910	K132443	000
07613353190903	K132443	000
07613353190897	K132443	000
07613353195939	K132443	000
07613353195922	K132443	000
07613353222093	K132443	000
07613353223038	K132443	000
07613353204846	K132443	000
07613353198183	K132443	000
07613353196127	K132443	000
07613353195724	K132443	000
07613353192631	K132443	000
07613353190958	K132443	000
07613353190965	K132443	000
07613353192655	K132443	000
07613353172404	K132443	000
07613353172398	K132443	000
07613353168162	K132443	000
07613353168155	K132443	000
07613353168148	K132443	000
07613353121761	K132443	000
07613353112301	K132443	000
07613353100094	K132443	000
07613353100087	K132443	000
07613353100070	K132443	000
07613353098360	K132443	000
07613353002466	K132443	000
07613353202705	K132443	000
07613353198176	K132443	000
07613353195175	K132443	000
07613353098377	K132443	000