510(k) K072144
- Device
- CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
- Applicant
- SMITHS MEDICAL MD, INC.
- 510(k) number
- K072144
- Product code
- MEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-07
- Date received
- 2007-08-02
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Pca
- 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
- PHIL NEURURER
- Address
- 1265 Grey Fox Rd. St. Paul MN US 55112 55112
FDA Registration Numbers#
- 3010381606
- 9680425
- 3003879246
- 3008717264
- 1055236
- 9617604
- 1047843
- 3009746061
- 3011270181
- 3009456923
- 3012307300
- 3024706751
- 3013652261
- 3002879653
- 9610825
- 3010082909
- 2029275
- 1319660
- 1043214
- 3012302888
- 2032112
- 3018071447
- 2025695
- 9615050
- 3013319212
- 3013764800
- 3007738736
- 1054241
- 2024064
- 2016493
- 3012337868
- 3004906872
Source Documents#
Other 510(k) Records For Product Code MEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | Summit Medical Products, Inc. | 2017-08-29 |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | 2017-08-24 |
| K143612 | LifeCare PCA Infusion System | Hospira, Inc. | 2016-04-08 |
| K130394 | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | Smiths Medical Asd, Inc. | 2013-12-09 |
| K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | B.Braun Medical, Inc. | 2009-11-04 |
| K051253 | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) | Baxter Healthcare Corp | 2005-07-15 |
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2004-12-10 |
| K043256 | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 | Hospira, Inc. | 2004-12-06 |
| K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | 2004-10-18 |
| K033054 | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP | Harvard Clinical Technology | 2003-12-16 |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2003-09-09 |
| K031566 | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | Baxter Healthcare Corp | 2003-08-19 |
| K030661 | STRYKER PAINPUMP2 | Stryker Instruments | 2003-05-30 |
| K020418 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | P.T. Greenleaf | 2003-04-29 |
| K020421 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Hennig Enterprises Europe Srl | 2003-04-29 |
Legacy Summary#
summary
FDA Review#
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