PERSONAL ALARM SYSTEM (PAS)

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

CYTOPROBE CORP.

The following data is part of a premarket notification filed by Cytoprobe Corp. with the FDA for Personal Alarm System (pas).

Pre-market Notification Details

• Device ID: K944961
• 510k Number: K944961
• Device Name: PERSONAL ALARM SYSTEM (PAS)
• 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: CYTOPROBE CORP. 9191 TOWNE CENRE DRIVE, SUITE 430 SAN DIEGO, CA 92122
• Contact: JOHN ZABSKY
• Correspondent: JOHN ZABSKY; CYTOPROBE CORP. 9191 TOWNE CENRE DRIVE, SUITE 430 SAN DIEGO, CA 92122
• Product Code: LDQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-07
• Decision Date: 1995-08-07