PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT— 510(k) K884421
Substantially EquivalentPymah Corp.
FDA 510(k) clearance K884421 for PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT, Substantially Equivalent on 1989-01-13. Applicant: Pymah Corp.. Device class: 2.
Clearance details
- Applicant
- Pymah Corp.
- 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
- Somerville, NJ, US
Recent devices under product code DXQ
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- K253964 — Disposable Neonatal NIBP Cuff (U1681S-C51N)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
More clearances from Pymah Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.