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FDA 510(k)

MED-OPEDIC SLEEP SYSTEM

K-Number: K834344 · 1984-01-17

ApplicantBemco Mattress Co.
Decision Date1984-01-17
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MED-OPEDIC SLEEP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bemco Mattress Co.. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K834344. 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 MED-OPEDIC SLEEP SYSTEM?

MED-OPEDIC SLEEP SYSTEM is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Bemco Mattress Co.. The 510(k) number is K834344.

When did MED-OPEDIC SLEEP SYSTEM receive FDA 510(k) clearance?

MED-OPEDIC SLEEP SYSTEM received FDA 510(k) clearance on 1984-01-17, under 510(k) number K834344.

Who is the listed applicant for MED-OPEDIC SLEEP SYSTEM?

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

What is the FDA product code for MED-OPEDIC SLEEP SYSTEM?

The FDA product code for MED-OPEDIC SLEEP SYSTEM is INX.

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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.

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

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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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