The following data is part of a premarket notification filed by Lotus Technologies with the FDA for Seizure Emergency Equipment Kit; Seizure Kit.
| Device ID | K973176 |
| 510k Number | K973176 |
| Device Name: | SEIZURE EMERGENCY EQUIPMENT KIT; SEIZURE KIT |
| 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 | LOTUS TECHNOLOGIES 1215 RED RIVER ST. Austin, TX 78701 |
| Contact | Dilip J Karnik |
| Correspondent | Dilip J Karnik LOTUS TECHNOLOGIES 1215 RED RIVER ST. Austin, TX 78701 |
| Product Code | KGA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-11-21 |