FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUDIOTONE MODEL A97
K Number: K920092
·
Decision Jan 28, 1992
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
65
Review Days
20
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Basic Information
- Device Name
- AUDIOTONE MODEL A97
- K Number
- K920092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Miracle-Ear, Inc.
- Date Received
- January 8, 1992
- Decision Date
- January 28, 1992
- Product Code
- LYY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
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Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
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Powder-Free Latex examination gloves
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Non Sterile Powder Free Latex Examination Glove
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Other Clearances by Miracle-Ear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972346 | MIRACLE-EAR ITE DIGITAL | Jul 23, 1997 | Substantially Equivalent |
| K972344 | MIRACLE-EAR DIGITAL BTE | Jul 23, 1997 | Substantially Equivalent |
| K972345 | DAHLBERG/MIRACLE-EAR | Jul 23, 1997 | Substantially Equivalent |
| K970262 | MULTI-CHANNEL COMPRESSION BTE (SD) | Mar 31, 1997 | Substantially Equivalent |
| K964419 | MIRACLE - EAR (ITE/ITC/CIC) | Feb 4, 1997 | Substantially Equivalent |
| K965057 | AUDIOTONE (A554H) | Jan 27, 1997 | Substantially Equivalent |
| K965063 | AUDIOTONE (A-552) | Jan 27, 1997 | Substantially Equivalent |
| K965049 | DAHLBERG (A-554) | Jan 27, 1997 | Substantially Equivalent |
| K964669 | MIRACLE-EAR OR AUDIOTONE | Dec 26, 1996 | Substantially Equivalent |
| K964794 | DAHLBERG K-AMP BTE | Dec 23, 1996 | Substantially Equivalent |