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FDA 510(k)

OPPURTUNITY TRACHEOSTOMY CARE KIT

K-Number: K971091 · 1997-09-16

ApplicantOpportunity, Inc.
Decision Date1997-09-16
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPPURTUNITY TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Opportunity, Inc.. It received FDA 510(k) clearance on 1997-09-16 under 510(k) number K971091. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPPURTUNITY TRACHEOSTOMY CARE KIT?

OPPURTUNITY TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1997-09-16. The listed applicant is Opportunity, Inc.. The 510(k) number is K971091.

When did OPPURTUNITY TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?

OPPURTUNITY TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1997-09-16, under 510(k) number K971091.

Who is the listed applicant for OPPURTUNITY TRACHEOSTOMY CARE KIT?

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

What is the FDA product code for OPPURTUNITY TRACHEOSTOMY CARE KIT?

The FDA product code for OPPURTUNITY TRACHEOSTOMY CARE KIT is KMF.

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Other records listing Opportunity, 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.

K971089OPPORTUNITY, INC. LACERATION TRAYK971088OPPORTUNITY INCISION AND DRAINAGE TRAYK971093OPPORTUNITY I.V. START KITK971090OPPORTUNITY DRESSING CHANGE TRAYK971095OPPORTUNITY SUTURE REMOVAL KITK971061OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

View all 8 devices →

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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