ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM— 510(k) K994346

Clearance details

Applicant

Sendx Medical, Inc.

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

1999-12-23

Decision date

2000-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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Death

20

Malfunction

999

Total

1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →