The following data is part of a premarket notification filed by Hidalgo Limited with the FDA for Equivital.
| Device ID | K113054 |
| 510k Number | K113054 |
| Device Name: | EQUIVITAL |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | HIDALGO LIMITED Unit F Buckinghamway Business Park Anderson Rd, Swavesey Cambridge, GB Cb24 4uq |
| Contact | Ekta Sood |
| Correspondent | Ekta Sood HIDALGO LIMITED Unit F Buckinghamway Business Park Anderson Rd, Swavesey Cambridge, GB Cb24 4uq |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-13 |
| Decision Date | 2012-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060483830100 | K113054 | 000 |
| 05060483830124 | K113054 | 000 |
| 05060483830131 | K113054 | 000 |
| 05060483830001 | K113054 | 000 |
| 05060483830018 | K113054 | 000 |
| 05060483830025 | K113054 | 000 |
| 05060483830032 | K113054 | 000 |
| 05060483830049 | K113054 | 000 |
| 05060483830056 | K113054 | 000 |
| 05060483830063 | K113054 | 000 |
| 05060483830070 | K113054 | 000 |
| 05060483830087 | K113054 | 000 |
| 05060483830094 | K113054 | 000 |
| 05060483830117 | K113054 | 000 |