The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Vital Signs Monitor.
| Device ID | K112465 |
| 510k Number | K112465 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Oximeter |
| Applicant | ADVANCED INSTRUMENTS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-26 |
| Decision Date | 2011-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510VSM300A1 | K112465 | 000 |
| B510VSM3001 | K112465 | 000 |