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FDA 510(k)

POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09

K-Number: K091296 · 2009-07-17

ApplicantPolymap Wireless
Decision Date2009-07-17
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 is the device name listed in this FDA 510(k) record. The listed applicant is Polymap Wireless. It received FDA 510(k) clearance on 2009-07-17 under 510(k) number K091296. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09?

POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 is a medical device that received FDA 510(k) clearance on 2009-07-17. The listed applicant is Polymap Wireless. The 510(k) number is K091296.

When did POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 receive FDA 510(k) clearance?

POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 received FDA 510(k) clearance on 2009-07-17, under 510(k) number K091296.

Who is the listed applicant for POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09?

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

What is the FDA product code for POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09?

The FDA product code for POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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.

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Other records listing Polymap Wireless 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.

K070559POLYMAP PWR-08-03

Related Devices (Code: NBW)

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.

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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.

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