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FDA 510(k)

EYE BUBBLE

K-Number: K912367 · 1991-10-02

ApplicantAaron Medical Industries
Decision Date1991-10-02
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE BUBBLE is the device name listed in this FDA 510(k) record. The listed applicant is Aaron Medical Industries. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K912367. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE BUBBLE?

EYE BUBBLE is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Aaron Medical Industries. The 510(k) number is K912367.

When did EYE BUBBLE receive FDA 510(k) clearance?

EYE BUBBLE received FDA 510(k) clearance on 1991-10-02, under 510(k) number K912367.

Who is the listed applicant for EYE BUBBLE?

The FDA 510(k) record lists Aaron Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE BUBBLE?

The FDA product code for EYE BUBBLE is HOY.

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Other records listing Aaron Medical Industries 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.

K062337MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTORK061307BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACKK060117BOVIE BUTTON REMOTE HAND SWITCHK022856BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATORK021817AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240VK020579AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03

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Related Devices (Code: HOY)

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.

K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEMOphthocare , Ltd.K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.K944700ARCTIC PREMIER SERIESSungold Eyewear, Inc.K944857GOGGLE SAFEGUARDSellstrom Mfg. Co.K945351SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, 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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