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FDA 510(k)

PULSE TIME PRODUCTS LIMITED, PM-2

K-Number: K892794 · 1989-08-25

ApplicantPulse Time Products, Ltd.
Decision Date1989-08-25
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE TIME PRODUCTS LIMITED, PM-2 is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Time Products, Ltd.. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K892794. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE TIME PRODUCTS LIMITED, PM-2?

PULSE TIME PRODUCTS LIMITED, PM-2 is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Pulse Time Products, Ltd.. The 510(k) number is K892794.

When did PULSE TIME PRODUCTS LIMITED, PM-2 receive FDA 510(k) clearance?

PULSE TIME PRODUCTS LIMITED, PM-2 received FDA 510(k) clearance on 1989-08-25, under 510(k) number K892794.

Who is the listed applicant for PULSE TIME PRODUCTS LIMITED, PM-2?

The FDA 510(k) record lists Pulse Time Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSE TIME PRODUCTS LIMITED, PM-2?

The FDA product code for PULSE TIME PRODUCTS LIMITED, PM-2 is DRT.

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 Pulse Time Products, Ltd. 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.

K901392BP50 BLOOD PRESSURE AND PULSE MONITORK892795PULSE TIME PRODUCTS LIMITED, PM-3K864411PULSE/B.P. MONITORK864748PM-8 HEART RATE MONITORK811425CARDIACMONITORS

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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.

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