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FDA 510(k)

BC 1400 HAND POSITIONER

K-Number: K872316 · 1987-08-12

ApplicantInstrumentation Industries, Inc.
Decision Date1987-08-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BC 1400 HAND POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872316. 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 BC 1400 HAND POSITIONER?

BC 1400 HAND POSITIONER is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K872316.

When did BC 1400 HAND POSITIONER receive FDA 510(k) clearance?

BC 1400 HAND POSITIONER received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872316.

Who is the listed applicant for BC 1400 HAND POSITIONER?

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

What is the FDA product code for BC 1400 HAND POSITIONER?

The FDA product code for BC 1400 HAND POSITIONER is KPR.

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Other records listing Instrumentation Industries, Inc. as applicant

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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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