SERVOMED BASIC BEDSIDE UNIT SMV 107
FDA 510(k) clearance K831782 · decided 1983-11-16
Clearance details
- K-number
- K831782
- Device name
- SERVOMED BASIC BEDSIDE UNIT SMV 107
- Applicant
- Litton Medical Electronics
- Decision
- Substantially Equivalent
- Date received
- 1983-06-02
- Decision date
- 1983-11-16
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |
| Essence 55S Large Monitor System (K172969) | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 |
| Sorin Connect (K170460) | Sorin Group Deutschland GmbH | 2017-06-08 |
| Nexxis OR, Nexxis (K170537) | Barco N.V. | 2017-04-21 |
| NIVR58-T kit (K161880) | Barco N.V. | 2017-03-14 |
| Philips IntelliVue GuardianSoftware (K161767) | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 |
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |
Recalls involving this device
No recalls on record reference this clearance.