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FDA 510(k)

NEO-WAVE SYSTEM

K-Number: K810543 · 1981-03-06

ApplicantGaymar Industries, Inc.
Decision Date1981-03-06
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEO-WAVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1981-03-06 under 510(k) number K810543. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-WAVE SYSTEM?

NEO-WAVE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-03-06. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K810543.

When did NEO-WAVE SYSTEM receive FDA 510(k) clearance?

NEO-WAVE SYSTEM received FDA 510(k) clearance on 1981-03-06, under 510(k) number K810543.

Who is the listed applicant for NEO-WAVE SYSTEM?

The FDA 510(k) record lists Gaymar Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO-WAVE SYSTEM?

The FDA product code for NEO-WAVE SYSTEM is INX.

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Other records listing Gaymar Industries, Inc. 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.

K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000

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Related Devices (Code: INX)

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K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, Inc.

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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