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FDA 510(k)

PIVOTING COMPENSATING FILTERS FOR THE HEAD

K-Number: K972766 · 1997-08-14

ApplicantOctostop, Inc.
Decision Date1997-08-14
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PIVOTING COMPENSATING FILTERS FOR THE HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Octostop, Inc.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K972766. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIVOTING COMPENSATING FILTERS FOR THE HEAD?

PIVOTING COMPENSATING FILTERS FOR THE HEAD is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Octostop, Inc.. The 510(k) number is K972766.

When did PIVOTING COMPENSATING FILTERS FOR THE HEAD receive FDA 510(k) clearance?

PIVOTING COMPENSATING FILTERS FOR THE HEAD received FDA 510(k) clearance on 1997-08-14, under 510(k) number K972766.

Who is the listed applicant for PIVOTING COMPENSATING FILTERS FOR THE HEAD?

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

What is the FDA product code for PIVOTING COMPENSATING FILTERS FOR THE HEAD?

The FDA product code for PIVOTING COMPENSATING FILTERS FOR THE HEAD is KPR.

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Other records listing Octostop, 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.

K963941THE PHARAOH COMPENSATING FILTERK953246OCTOROLLK952871RIDGES PLUSK942916OCTOPAQUE UNIVERSALK940306OCTOSTOP COMPENSATING FILTERSK935444OCTOSTOP(R) CHAIR (NEW MODEL

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Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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