The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Ibm 5880 Acquisition & Analysis Cart Tel.
Device ID | K810989 |
510k Number | K810989 |
Device Name: | IBM 5880 ACQUISITION & ANALYSIS CART TEL |
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 | INTL. BUSINESS MACHINES 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 | 1981-04-13 |
Decision Date | 1981-05-01 |