FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EYE BUBBLE
K Number: K912367
·
Decision Oct 2, 1991
Classifications
1
FEI Numbers
712
Registration Numbers
712
Same Product Code
54
Applicant Total
46
Review Days
126
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Basic Information
- Device Name
- EYE BUBBLE
- K Number
- K912367
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4750
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aaron Medical Industries
- Date Received
- May 29, 1991
- Decision Date
- October 2, 1991
- Product Code
- HOY
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | FDA class 1 | Ophthalmic |
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Other Clearances by Aaron Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K062337 | MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR | Oct 5, 2006 | Substantially Equivalent |
| K061307 | BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK | Jul 18, 2006 | Substantially Equivalent |
| K060117 | BOVIE BUTTON REMOTE HAND SWITCH | Feb 22, 2006 | Substantially Equivalent |
| K022856 | BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Feb 10, 2003 | Substantially Equivalent |
| K021817 | AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V | Jul 11, 2002 | Substantially Equivalent |
| K020579 | AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03 | May 13, 2002 | Substantially Equivalent |
| K014201 | AARON REUSABLE ELECTROSURGICAL ELECTRODE | Feb 25, 2002 | Substantially Equivalent |
| K001955 | AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 | Dec 22, 2000 | Substantially Equivalent |
| K001382 | AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR | Jun 27, 2000 | Substantially Equivalent |
| K000961 | AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE | Apr 19, 2000 | Substantially Equivalent |