WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE— 510(k) K093907
Substantially EquivalentWelch Allyn, Inc.
FDA 510(k) clearance K093907 for WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE, Substantially Equivalent on 2010-04-14. Applicant: Welch Allyn, Inc.. Device class: 2.
Clearance details
- Applicant
- Welch Allyn, Inc.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Skaneateles Falls, NY, US
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Welch Allyn, Inc.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.