Patient Monitoring Cables— 510(k) K203635
Substantially EquivalentJkh USA, LLC
FDA 510(k) clearance K203635 for Patient Monitoring Cables, Substantially Equivalent on 2021-02-05. Applicant: Jkh USA, LLC. Device class: 2.
Clearance details
- Applicant
- Jkh USA, LLC
- Product code
- Product code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut, CA, US
Recent devices under product code DSA
view allMore clearances from Jkh USA, LLC
view all- K203636 — PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS +1 more
- K203652 — Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
- K202851 — Spo2 Sensor
- K201645 — Massage Compression Boots
- K201470 — Disposable Medical Face Mask
Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.