IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P— 510(k) K894748

Clearance details

Applicant

Singer Medical Products, Inc.

Product code

Code EWO

Device class

Class 2

Regulation

21 CFR 874.1050

Advisory panel

Ear, Nose, Throat

Date received

1989-07-26

Decision date

1989-12-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bensenville, IL, US

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• K905035 — AXOSTIM NERVE STIMULATOR, MODIFICATION1991-04-19
• K896909 — MD5 AUTOMATIC AUDIOMETER1990-03-05
• K895783 — IMPEDANCE ANALYZER MODELS MD-2, MD-P1989-12-05
• K895784 — IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-31989-12-05
• K895785 — AUDIOMETER MODEL MD-4, MD-4P1989-12-05

Other

2

Total

2

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 →