The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Am-6000 Anesthesia Machine.
| Device ID | K120075 |
| 510k Number | K120075 |
| Device Name: | AM-6000 ANESTHESIA MACHINE |
| Classification | Gas-machine, Anesthesia |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-10 |
| Decision Date | 2012-01-26 |
| Summary: | summary |