DUAL INCU I

Incubator, Neonatal

ATOM MEDICAL CORPORATION

The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Dual Incu I.

Pre-market Notification Details

• Device ID: K102226
• 510k Number: K102226
• Device Name: DUAL INCU I
• Classification: Incubator, Neonatal
• Applicant: ATOM MEDICAL CORPORATION 3-18-15 HONGO Bunkyo-ku, Tokyo, JP 113-0033
• Contact: Tsuyoshi Sugino
• Correspondent: Tsuyoshi Sugino; ATOM MEDICAL CORPORATION 3-18-15 HONGO Bunkyo-ku, Tokyo, JP 113-0033
• Product Code: FMZ
• CFR Regulation Number: 880.5400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-09
• Decision Date: 2011-01-04
• Summary: summary