BlueStar Rx
FDA 510(k) clearance K193654 · decided 2020-04-07
Clearance details
- K-number
- K193654
- Device name
- BlueStar Rx
- Applicant
- Welldoc, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-30
- Decision date
- 2020-04-07
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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| SpaceStation MRI (K191910) | B. Braun Melsugen AG | 2020-03-12 |
| WellDoc BlueStar (K190013) | Welldoc, Inc. | 2019-11-04 |
| Lockbox for Perfusor Space PCA Infusion Pump (K173531) | B.Braun Medical, Inc. | 2018-08-02 |
| Sapphire Sets (K171346) | Icu Medical | 2017-08-25 |
| WellDoc BlueStar, WellDoc BlueStar Rx (K162532) | Welldoc, Inc. | 2017-01-12 |
| Hospira Sapphire Sets (K160492) | Hospira, Inc. | 2016-12-06 |
| WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System (K162225) | Welldoc, Inc. | 2016-11-22 |
| ivWatch Model 400 (K142374) | Ivwatch, LLC | 2015-02-13 |
| SMART LABEL, PROPOFOL (K142333) | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 |
Recalls involving this device
No recalls on record reference this clearance.