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FDA 510(k)

PHYSIOGARD SM 785

K-Number: K885177 · 1989-03-31

ApplicantAdam
Decision Date1989-03-31
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOGARD SM 785 is the device name listed in this FDA 510(k) record. The listed applicant is Adam. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K885177. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOGARD SM 785?

PHYSIOGARD SM 785 is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Adam. The 510(k) number is K885177.

When did PHYSIOGARD SM 785 receive FDA 510(k) clearance?

PHYSIOGARD SM 785 received FDA 510(k) clearance on 1989-03-31, under 510(k) number K885177.

Who is the listed applicant for PHYSIOGARD SM 785?

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

What is the FDA product code for PHYSIOGARD SM 785?

The FDA product code for PHYSIOGARD SM 785 is DPS.

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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