510(k) K141193
- Device
- MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
- Applicant
- SMITHS MEDICAL ASD, INC.
- 510(k) number
- K141193
- Product code
- PHC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-25
- Date received
- 2014-05-08
- Regulation
- 880.5725
- Classification name
- Infusion Safety Management Software
- 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
- TOM BLISS
- Address
- 1265 Grey Fox Rd. St. Paul MN US 55112 55112
FDA Registration Numbers#
- 9612051
- 9617594
- 3003879246
- 1416980
- 1018233
- 1047843
- 3012307300
- 3005210579
- 3010972758
- 3024706751
- 3015158050
- 3000240707
- 1319660
- 1643817
- 9615050
- 3013319212
- 3007738736
- 3005778453
- 1314492
- 3014732157
- 2024064
- 2016493
- 3012337868
- 3015437214
- 3004906872
- 1423507
Source Documents#
Other 510(k) Records For Product Code PHC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2026-04-02 |
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson | 2025-06-20 |
| K242117 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | 2025-04-02 |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2024-03-29 |
| K223606 | LifeShield™ Infusion Safety Software Suite | Icu Medical, Inc. | 2023-08-24 |
| K211124 | Dose IQ Safety Software | Baxter Healthcare Corporation | 2022-08-30 |
| K210075 | Vigilant Software Suite – Vigilant Master Med | Fresenius Kabi AG | 2022-03-01 |
| K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019-04-30 |
| K141474 | BECTON DICKINSON INTELLIPORT SYSTEM | Becton, Dickinson & CO | 2014-12-18 |
Legacy Summary#
summary
FDA Review#
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