HEART 1001— 510(k) K931020

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K931020 for HEART 1001, Substantially Equivalent on 1995-01-11. Applicant: Aerotel, Ltd.. Device class: 2.

Clearance details

Applicant: Aerotel, Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1993-02-26
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aerotel, Ltd.

K980144 — HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER1998-06-16
K953762 — HEART 400 ECG TRANSMITTER1996-07-18
K961362 — AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE1996-07-10
K950004 — HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER1995-10-24
K930314 — HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE1994-03-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.