Data / Medical devices / United States / Smart Choice Medical Inc.
Smart Choice Medical Inc.: FDA-registered device maker in Sylmar, CA, United States, 1 510(k) clearance
Smart Choice Medical Inc. is registered with the FDA (registration 3012243264) in Sylmar, CA, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012243264
- Address
- 15823 Monte St Unit E105, Sylmar, CA, United States, 91342
- Owner or operator
- Smart Choice Medical Inc (10051227)
- Roles
- Repackager or relabeler
- First device listed
- February 19, 2016
- Registered through
- 2026
- Brand names listed
- ACCESSORY, SURGICAL APPAREL, BEDDING, DISPOSABLE, MEDICAL, COVER, MATTRESS (MEDICAL PURPOSES), GARMENT, PROTECTIVE, FOR INCONTINENCE, Oximeter, Respirator, surgical
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2018 | K173123 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Imdk Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Oximeter
- All makers of Garment, Protective, For Incontinence
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Accessory, Surgical Apparel
- All makers of Bedding, Disposable, Medical
Updated August 13, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.