510(k) K142374
- Device
- IvWatch Model 400
- Applicant
- IvWatch, LLC
- 510(k) number
- K142374
- Product code
- MRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-13
- Date received
- 2014-08-26
- Regulation
- 880.5725
- Classification name
- Accessories, Pump, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Javier Garriz
- Address
- 469 Mclaws Cir. Williamsburg VA US 23185 23185
FDA Registration Numbers#
- 3007981285
- 3010223109
- 3011806823
- 3023851856
- 3004906872
- 9610825
- 8043459
- 3003098013
- 9615050
- 9616814
- 3009456923
- 3012337868
- 3008770957
- 1121996
- 3013764800
- 3018071447
- 3009712113
- 3000240707
- 3013756811
- 3007738736
- 3023228837
- 3010184418
- 3011490091
- 2521402
- 2032112
- 2030624
- 1047843
- 1643817
- 2032227
- 3012307300
- 2183715
- 3013319212
- 3020460367
- 9611612
- 3006534321
- 3010293992
- 3004365956
Source Documents#
Other 510(k) Records For Product Code MRZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230718 | UTC 3mL Medication Cartridge | Gilero, LLC | 2023-06-15 |
| K220695 | Elite Biomedical Solutions Dose Request Cord | Elite Biomedical Solutions | 2022-04-29 |
| K201634 | RG 3ml Medication Cartridge | Chengdu Shifeng Medical Technology Co., Ltd. | 2021-03-26 |
| K193654 | BlueStar Rx | Welldoc, Inc. | 2020-04-07 |
| K191910 | SpaceStation MRI | B. Braun Melsugen AG | 2020-03-12 |
| K190013 | WellDoc BlueStar | Welldoc, Inc. | 2019-11-04 |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | B.Braun Medical, Inc. | 2018-08-02 |
| K171346 | Sapphire Sets | Icu Medical | 2017-08-25 |
| K162532 | WellDoc BlueStar, WellDoc BlueStar Rx | Welldoc, Inc. | 2017-01-12 |
| K160492 | Hospira Sapphire Sets | Hospira, Inc. | 2016-12-06 |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System | Welldoc, Inc. | 2016-11-22 |
| K142333 | SMART LABEL, PROPOFOL | American I.V. Products, Inc. Dba Aiv, Inc. | 2014-12-18 |
| K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE | Welldoc, Inc. | 2014-07-08 |
| K132618 | ONETOUCH REVEAL | Lifescan, Inc. | 2013-12-16 |
| K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE | American I.V. Products, Inc. | 2012-04-12 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases