ABN ANEROID SPHYGMOMANOMETER— 510(k) K012444
Substantially EquivalentPt. Sugih Instrumendo Abadi
FDA 510(k) clearance K012444 for ABN ANEROID SPHYGMOMANOMETER, Substantially Equivalent on 2001-08-16. Applicant: Pt. Sugih Instrumendo Abadi. Device class: 2.
Clearance details
- Applicant
- Pt. Sugih Instrumendo Abadi
- Product code
- Code DXQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Recent devices under product code DXQ
view all- K254287 — Medline Reusable Blood Pressure Cuff
- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
Data sourced from openFDA. This site is unofficial and independent of the FDA.