ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M

Electrosurgical, Cutting & Coagulation & Accessories

ELMED, INC.

The following data is part of a premarket notification filed by Elmed, Inc. with the FDA for Electrosurgical Units Esu 100l, 100 L M/m & E M/m.

Pre-market Notification Details

• Device ID: K921770
• 510k Number: K921770
• Device Name: ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101
• Contact: Karl Hausner
• Correspondent: Karl Hausner; ELMED, INC. 60 WEST FAY AVE. Addison, IL 60101
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-04-13
• Decision Date: 1993-05-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B382SD75260	K921770	000
B382SD82010	K921770	000
B382SD75460	K921770	000