OXYCONALPHA WITH OPTION ECG

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

ERICH JAEGER B.V.

The following data is part of a premarket notification filed by Erich Jaeger B.v. with the FDA for Oxyconalpha With Option Ecg.

Pre-market Notification Details

• Device ID: K984465
• 510k Number: K984465
• Device Name: OXYCONALPHA WITH OPTION ECG
• 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: ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981
• Contact: Leon Den Bakker
• Correspondent: Leon Den Bakker; ERICH JAEGER B.V. REGULIERENING 11 Nl-3981 La Bunnik, NL Nl-3981
• 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: 1998-12-16
• Decision Date: 1999-10-27