The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Pagewriter 200i Interpretive Cardiograph Model M1770a With Acute Cardiac Ischemia Time Insensitive Predictive Instrumena.
| Device ID | K981265 |
| 510k Number | K981265 |
| Device Name: | PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA |
| 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 | HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Renee J Thibeault |
| Correspondent | Renee J Thibeault HEWLETT-PACKARD CO. 49 PLAIN ST. North Attleboro, MA 02760 |
| 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 | 1998-04-07 |
| Decision Date | 1998-06-23 |
| Summary: | summary |