ATMOSET

Unit, Examining/treatment, Ent

JEDMED INSTRUMENT CO.

The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Atmoset.

Pre-market Notification Details

• Device ID: K810148
• 510k Number: K810148
• Device Name: ATMOSET
• Classification: Unit, Examining/treatment, Ent
• Applicant: JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ETF
• CFR Regulation Number: 874.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-01-21
• Decision Date: 1981-02-17