ADMARK

System, X-ray, Film Marking, Radiographic

PLANMECA USA, INC.

The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Admark.

Pre-market Notification Details

• Device ID: K923533
• 510k Number: K923533
• Device Name: ADMARK
• Classification: System, X-ray, Film Marking, Radiographic
• Applicant: PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI
• Contact: Ismo Seppa
• Correspondent: Ismo Seppa; PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI
• Product Code: JAC
• CFR Regulation Number: 892.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-16
• Decision Date: 1993-03-04