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FDA 510(k)

HOME CARE BEAD BED

K-Number: K972176 · 1998-01-16

ApplicantKinetic Concepts, Inc.
Decision Date1998-01-16
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOME CARE BEAD BED is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1998-01-16 under 510(k) number K972176. 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 HOME CARE BEAD BED?

HOME CARE BEAD BED is a medical device that received FDA 510(k) clearance on 1998-01-16. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K972176.

When did HOME CARE BEAD BED receive FDA 510(k) clearance?

HOME CARE BEAD BED received FDA 510(k) clearance on 1998-01-16, under 510(k) number K972176.

Who is the listed applicant for HOME CARE BEAD BED?

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

What is the FDA product code for HOME CARE BEAD BED?

The FDA product code for HOME CARE BEAD BED is INX.

Other records listing Kinetic Concepts, Inc. as applicant

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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.

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.K924973DYLNAMEDICS A.S.A.P.Dynamedics, 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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