EPAD

Stimulator, Electrical, Evoked Response

SAFEOP SURGICAL, INC.

The following data is part of a premarket notification filed by Safeop Surgical, Inc. with the FDA for Epad.

Pre-market Notification Details

• Device ID: K132616
• 510k Number: K132616
• Device Name: EPAD
• Classification: Stimulator, Electrical, Evoked Response
• Applicant: SAFEOP SURGICAL, INC. 125 CHERRY LN. Amherst, MA 01002
• Contact: Sheila Hemeon-heyer
• Correspondent: Sheila Hemeon-heyer; SAFEOP SURGICAL, INC. 125 CHERRY LN. Amherst, MA 01002
• Product Code: GWF
• Subsequent Product Code: GXY
• Subsequent Product Code: IKN
• CFR Regulation Number: 882.1870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-21
• Decision Date: 2014-01-24
• Summary: summary