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FDA 510(k)

RADIOISOTOPE CALIBRATOR (CRCO-22NB)

K-Number: K761145 · 1976-12-16

ApplicantG.D. Searle and Co.
Decision Date1976-12-16
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RADIOISOTOPE CALIBRATOR (CRCO-22NB) is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1976-12-16 under 510(k) number K761145. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOISOTOPE CALIBRATOR (CRCO-22NB)?

RADIOISOTOPE CALIBRATOR (CRCO-22NB) is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is G.D. Searle and Co.. The 510(k) number is K761145.

When did RADIOISOTOPE CALIBRATOR (CRCO-22NB) receive FDA 510(k) clearance?

RADIOISOTOPE CALIBRATOR (CRCO-22NB) received FDA 510(k) clearance on 1976-12-16, under 510(k) number K761145.

Who is the listed applicant for RADIOISOTOPE CALIBRATOR (CRCO-22NB)?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOISOTOPE CALIBRATOR (CRCO-22NB)?

The FDA product code for RADIOISOTOPE CALIBRATOR (CRCO-22NB) is KPI.

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Other records listing G.D. Searle and Co. as applicant

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Related Devices (Code: KPI)

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.

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag

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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