The following data is part of a premarket notification filed by Hidalgo Limited with the FDA for Equivital, Model Eq-01.
| Device ID | K061993 |
| 510k Number | K061993 |
| Device Name: | EQUIVITAL, MODEL EQ-01 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | HIDALGO LIMITED STABLE BLOCK AT THE GRANGE 20 MARKET STREET Swavesey Cambridge, GB Cb4-5qg |
| Contact | Justin Pisani |
| Correspondent | Justin Pisani HIDALGO LIMITED STABLE BLOCK AT THE GRANGE 20 MARKET STREET Swavesey Cambridge, GB Cb4-5qg |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-14 |
| Decision Date | 2006-11-03 |
| Summary: | summary |