TELAMAT— 510(k) K864749

Substantially Equivalent

Comet Ltd. C/O Radiology Resources, Inc.

FDA 510(k) clearance K864749 for TELAMAT, Substantially Equivalent on 1987-02-10. Applicant: Comet Ltd. C/O Radiology Resources, Inc..

Clearance details

Applicant: Comet Ltd. C/O Radiology Resources, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1986-12-05
Decision date: 1987-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worburn, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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 →

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