FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TAP 3, TAP 1
K Number: K160239
·
Decision Aug 10, 2016
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
8
Applicant Total
6
Review Days
191
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Basic Information
- Device Name
- TAP 3, TAP 1
- K Number
- K160239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Airway Management, Inc.
- Date Received
- February 1, 2016
- Decision Date
- August 10, 2016
- Product Code
- PLC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| PLC | Sleep Appliances With Patient Monitoring | FDA class 2 | Dental |
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Other Clearances by Airway Management, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181482 | myTAP2 | Aug 31, 2018 | Substantially Equivalent |
| K122350 | TAP PAP NASAL PILLOW MASK | Nov 1, 2012 | Substantially Equivalent |
| K062951 | TAP III ANTI-SNORING DEVICE | Dec 12, 2006 | Substantially Equivalent |
| K061732 | TAP-T | Jul 12, 2006 | Substantially Equivalent |
| K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT | May 17, 2006 | Substantially Equivalent |