CARDIO ANALYZER MODEL 380

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

BIRTCHER CORP.

The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Cardio Analyzer Model 380.

Pre-market Notification Details

• Device ID: K844104
• 510k Number: K844104
• Device Name: CARDIO ANALYZER MODEL 380
• 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: BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731
• Contact: Enrique Rangel
• Correspondent: Enrique Rangel; BIRTCHER CORP. 4501 N. ARDEN DR. P.O. BOX 4399 El Monte, CA 91731
• 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: 1984-10-23
• Decision Date: 1985-03-06