The following data is part of a premarket notification filed by Datascope Corp., Patient Monitoring Division with the FDA for A5 Anesthesia Delivery System.
| Device ID | K123211 |
| 510k Number | K123211 |
| Device Name: | A5 ANESTHESIA DELIVERY SYSTEM |
| Classification | Gas-machine, Anesthesia |
| Applicant | DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen DATASCOPE CORP., PATIENT MONITORING DIVISION 800 MACARTHUR BLVD. Mahwah, NJ 07430 -0619 |
| Product Code | BSZ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904055091 | K123211 | 000 |
| 06944904030272 | K123211 | 000 |
| 06944904095462 | K123211 | 000 |
| 06944904093314 | K123211 | 000 |