The following data is part of a premarket notification filed by Novatec Medical Products, Inc.--glove Monitor with the FDA for Surgic-alert Monitor.
| Device ID | K930514 |
| 510k Number | K930514 |
| Device Name: | SURGIC-ALERT MONITOR |
| 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 | NOVATEC MEDICAL PRODUCTS, INC.--GLOVE MONITOR 305 MAYERLING DR. Houston, TX 77024 |
| Contact | William Marshall |
| Correspondent | William Marshall NOVATEC MEDICAL PRODUCTS, INC.--GLOVE MONITOR 305 MAYERLING DR. Houston, TX 77024 |
| 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 | 1993-02-01 |
| Decision Date | 1993-08-19 |