HIMOBILIX 2N— 510(k) K883161

Name: FDA 510(k) clearance K883161
Creator: U.S. Food and Drug Administration
Published: 1988-10-21

Substantially Equivalent

Bay X-Ray, Inc.

FDA 510(k) clearance K883161 for HIMOBILIX 2N, Substantially Equivalent on 1988-10-21. Applicant: Bay X-Ray, Inc.. Device class: 2.

Clearance details

Applicant: Bay X-Ray, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 1988-07-26
Decision date: 1988-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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K883160 — CATAPULT BUCKY (KATAPULT BLENDA)1988-09-08
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K883155 — RASTIX X-RAY TABLE1988-09-06
K883162 — TELESTATIX X-RAY TABLE1988-09-06

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.