Data / Medical devices / United States / RemetricHealth Inc.
RemetricHealth Inc.: FDA-registered device maker in Allentown, PA, United States, 4 510(k) clearances
RemetricHealth Inc. is registered with the FDA (registration 3008935567) in Allentown, PA, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 2, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008935567
- Address
- 7584 Morris Ct Suite 218, Allentown, PA, United States, 18106
- Owner or operator
- RemetricHealth Inc (10038952)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 28, 2011
- Registered through
- 2026
- Brand names listed
- PMD Blood Pressure Monitor, PMD Pulse Oximeter, PMD Weight Scale, Spiro PD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Nose | BXJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| February 2, 2016 | K160014 | iHealth Track Blood Pressure Monitor | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| April 23, 2015 | K141362 | PULSE OXIMETER CMS50EW | DQA | Substantially Equivalent | Contec Medical Systems Co.,Ltd | accessdata.fda.gov |
| November 9, 2011 | K103575 | SPIRO PD | BZG | Substantially Equivalent | Pmd Healthcare | accessdata.fda.gov |
| November 10, 2008 | K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | Substantially Equivalent | Contec Medical System Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Spirometer, Diagnostic
- All makers of Clip, Nose
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Scale, Patient
- All makers of Medical Device Data System
Updated February 2, 2016. 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.