Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INFANT APNEA BED STIMULATOR AA-010

K-Number: K842607 · 1984-09-13

ApplicantAlpha Medical Systems
Decision Date1984-09-13
Product Code
DecisionSubstantially Equivalent

Device Summary

INFANT APNEA BED STIMULATOR AA-010 is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Medical Systems. It received FDA 510(k) clearance on 1984-09-13 under 510(k) number K842607. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT APNEA BED STIMULATOR AA-010?

INFANT APNEA BED STIMULATOR AA-010 is a medical device that received FDA 510(k) clearance on 1984-09-13. The listed applicant is Alpha Medical Systems. The 510(k) number is K842607.

When did INFANT APNEA BED STIMULATOR AA-010 receive FDA 510(k) clearance?

INFANT APNEA BED STIMULATOR AA-010 received FDA 510(k) clearance on 1984-09-13, under 510(k) number K842607.

Who is the listed applicant for INFANT APNEA BED STIMULATOR AA-010?

The FDA 510(k) record lists Alpha Medical Systems as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alpha Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842608INFANT PERCUSSOR PA-010

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑