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FDA 510(k)

PARAGON 8500 CARDIO-PULMONARY BED

K-Number: K872924 · 1987-10-09

ApplicantSurgi-Med, Inc.
Decision Date1987-10-09
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARAGON 8500 CARDIO-PULMONARY BED is the device name listed in this FDA 510(k) record. The listed applicant is Surgi-Med, Inc.. It received FDA 510(k) clearance on 1987-10-09 under 510(k) number K872924. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAGON 8500 CARDIO-PULMONARY BED?

PARAGON 8500 CARDIO-PULMONARY BED is a medical device that received FDA 510(k) clearance on 1987-10-09. The listed applicant is Surgi-Med, Inc.. The 510(k) number is K872924.

When did PARAGON 8500 CARDIO-PULMONARY BED receive FDA 510(k) clearance?

PARAGON 8500 CARDIO-PULMONARY BED received FDA 510(k) clearance on 1987-10-09, under 510(k) number K872924.

Who is the listed applicant for PARAGON 8500 CARDIO-PULMONARY BED?

The FDA 510(k) record lists Surgi-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAGON 8500 CARDIO-PULMONARY BED?

The FDA product code for PARAGON 8500 CARDIO-PULMONARY BED is FNL.

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 Surgi-Med, Inc. 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.

K881705MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEMK873047KEANE MOBILITY BEDK872923PARAGON 9000 TILT AND TURN BEDK872925MEGABED 1000

Related Devices (Code: FNL)

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.

K202964iBed Wireless with iBed MobileStryker CorporationK103536IBED WIRELESS WITH IBED AWARENESSStryker CorporationK982783VAIL 1000 ENCLOSED BEDVail Products, Inc.K974296MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BEDInvacare Corp.K974254BENEFIT B3--- SERIESM.C. Healthcare Products, Inc.K972115VOLKER HOSPITAL BED, MODEL K960Volker Healthcare, Inc.

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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