FDA 510(k)

PIE MEDICAL SCANNER 1000

K-Number: K870058 · 1988-02-02

Decision Date1988-02-02

Product CodeKNG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PIE MEDICAL SCANNER 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Pie Data Medical BV. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K870058. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIE MEDICAL SCANNER 1000?

PIE MEDICAL SCANNER 1000 is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Pie Data Medical BV. The 510(k) number is K870058.

When did PIE MEDICAL SCANNER 1000 receive FDA 510(k) clearance?

PIE MEDICAL SCANNER 1000 received FDA 510(k) clearance on 1988-02-02, under 510(k) number K870058.

Who is the listed applicant for PIE MEDICAL SCANNER 1000?

The FDA 510(k) record lists Pie Data Medical BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIE MEDICAL SCANNER 1000?

The FDA product code for PIE MEDICAL SCANNER 1000 is KNG.

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Other records listing Pie Data Medical BV as applicant

K874192MULTIPURPOSE TRANSDUCER RANGE K870653ULTRASOUND LINEAR/SECTOR SCANNER 1100 K874081ENTERSCAN K871082FETAL CARE MONITOR ANTEPARTUM 1500

Related Devices (Code: KNG)

K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd.K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd.K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,Ltd K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd K211940Fetal DopplerShenzhen Taikang Medical Equipment Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.