MICROCAP

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

ORIDION MEDICAL LTD.

The following data is part of a premarket notification filed by Oridion Medical Ltd. with the FDA for Microcap.

Pre-market Notification Details

• Device ID: K981114
• 510k Number: K981114
• Device Name: MICROCAP
• Classification: Analyzer, Gas, Carbon-dioxide, Gaseous-phase
• Applicant: ORIDION MEDICAL LTD. 7 HAMARPE ST. P.O. BOX 45025 Jerusalem, IL 91450
• Contact: Sanford Brown
• Correspondent: Sanford Brown; ORIDION MEDICAL LTD. 7 HAMARPE ST. P.O. BOX 45025 Jerusalem, IL 91450
• Product Code: CCK
• CFR Regulation Number: 868.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-27
• Decision Date: 1998-06-25