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FDA 510(k)

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM

K-Number: K881705 · 1988-07-13

ApplicantSurgi-Med, Inc.
Decision Date1988-07-13
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM 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 1988-07-13 under 510(k) number K881705. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM?

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-13. The listed applicant is Surgi-Med, Inc.. The 510(k) number is K881705.

When did MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM receive FDA 510(k) clearance?

MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM received FDA 510(k) clearance on 1988-07-13, under 510(k) number K881705.

Who is the listed applicant for MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM?

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 MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM?

The FDA product code for MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM is INX.

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.

K873047KEANE MOBILITY BEDK872923PARAGON 9000 TILT AND TURN BEDK872924PARAGON 8500 CARDIO-PULMONARY BEDK872925MEGABED 1000

Related Devices (Code: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, 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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