CARDIO-CARD INTERPRETATION SYSTEM I

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

NASIFF ASSOC., INC.

The following data is part of a premarket notification filed by Nasiff Assoc., Inc. with the FDA for Cardio-card Interpretation System I.

Pre-market Notification Details

• Device ID: K993616
• 510k Number: K993616
• Device Name: CARDIO-CARD INTERPRETATION SYSTEM I
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: NASIFF ASSOC., INC. 9422 LEBEAU LN. Brewerton, NY 13029
• Contact: Roger E Nasiff
• Correspondent: Roger E Nasiff; NASIFF ASSOC., INC. 9422 LEBEAU LN. Brewerton, NY 13029
• Product Code: LOS
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-10-26
• Decision Date: 2000-04-10