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FDA 510(k)

HORTMANN AIRMATIC AIR CALORIC STIMULATOR

K-Number: K950785 · 1995-06-28

ApplicantJedmed Instrument Co.
Decision Date1995-06-28
Product CodeKHH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HORTMANN AIRMATIC AIR CALORIC STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Jedmed Instrument Co.. It received FDA 510(k) clearance on 1995-06-28 under 510(k) number K950785. The device is classified under product code KHH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORTMANN AIRMATIC AIR CALORIC STIMULATOR?

HORTMANN AIRMATIC AIR CALORIC STIMULATOR is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is Jedmed Instrument Co.. The 510(k) number is K950785.

When did HORTMANN AIRMATIC AIR CALORIC STIMULATOR receive FDA 510(k) clearance?

HORTMANN AIRMATIC AIR CALORIC STIMULATOR received FDA 510(k) clearance on 1995-06-28, under 510(k) number K950785.

Who is the listed applicant for HORTMANN AIRMATIC AIR CALORIC STIMULATOR?

The FDA 510(k) record lists Jedmed Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HORTMANN AIRMATIC AIR CALORIC STIMULATOR?

The FDA product code for HORTMANN AIRMATIC AIR CALORIC STIMULATOR is KHH.

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Other records listing Jedmed Instrument Co. 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.

K021750LID CHAIN EYELID WEIGHTSK954184JED-LIGHT FIBEROPTIC LIGHT SOURCEK944032VIDEO SCOPE SYSTEM (LARYNGOSCOPE)K953457JEDMED SPECTRUM ENT CABINETK950925JEDMED LARYNGEAL SCOPEK950078MICROFLOW IRRIGATION SYSTEM

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Related Devices (Code: KHH)

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.

K946108EAR-A-GATORLife-Tech Intl., Inc.K941325WATER IRRIGATOR, W1 200Strong Medical, Inc.K931608NCA-200Ics Medical Corp.K925237AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K881630AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K822179FRENZEL EYEGLASSES & RELATED ITEMSKelleher Corp.

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.

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