Product code DSJ
- Device name
- Alarm, Blood-Pressure
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1100
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017-03-31 |
| K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015-09-29 |
| K133961 | SURESIGNS VS3, SURESIGNS VS4 | Philips Medical Systems | 2014-06-26 |
| K960916 | SAMS 8000 CARDIOPLEGIA MONITOR | 3M Health Care, Sarns | 1996-06-04 |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | Keller Medical Specialties Products, Inc. | 1991-04-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278522313 | CARESCAPE Canvas Smart Display | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278522320 | CARESCAPE Canvas 1000 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278523365 | CARESCAPE Canvas D19 | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278524089 | NA | GE Healthcare Finland Oy | 2023-04-19 |
| 00195278288639 | CARESCAPE ONE | Ge Medical Systems Information Technologies, Inc. | 2022-05-13 |
| 00840682141291 | B1X5 Software Upgrade | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2020-11-18 |
| 00840682138581 | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2020-11-16 |
| 00840682138574 | NA | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2020-11-16 |
| 00840682143806 | CARESCAPE B650 | GE Healthcare Finland Oy | 2020-03-11 |
| 00840682142380 | CARESCAPE B450 | GE Healthcare Finland Oy | 2020-03-09 |
| 00840682144308 | CARESCAPE B850 | GE Healthcare Finland Oy | 2020-03-05 |
| 00840682123433 | CARESCAPE RAD | GE Healthcare Finland Oy | 2020-03-05 |
| 18904269452886 | STAR 65 | SKANRAY TECHNOLOGIES LIMITED | 2019-01-21 |
| 00840682118262 | CARESCAPE | GE Healthcare Finland Oy | 2017-03-15 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 20884838028726 | Genius 2 | Philips Medical Systems Hsg | 2016-10-05 |
| 00840682107761 | CARESCAPE | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682108263 | CARESCAPE | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682108379 | CARESCAPE | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104463 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104456 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104449 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104432 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682104425 | NA | GE Healthcare Finland Oy | 2016-07-22 |
| 00840682116800 | NA | GE Healthcare Finland Oy | 2016-06-30 |
| 00840682105200 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105224 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682105118 | CARESCAPE | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682103978 | NA | GE Healthcare Finland Oy | 2016-06-03 |
| 00840682103930 | CARESCAPE | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | 2016-06-03 |