The following data is part of a premarket notification filed by Datascope Corp., Patient Monitoring Division with the FDA for Navigator Anesthesia Delivery System, Model 0998-00-3024-01.
| Device ID | K080175 |
| 510k Number | K080175 |
| Device Name: | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Kathleen Kramer |
| Correspondent | Kathleen Kramer DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-06-09 |
| Summary: | summary |