FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDTECH C.P.R. MASK
K Number: K862199
·
Decision Jun 13, 1986
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
2
Review Days
3
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Basic Information
- Device Name
- MEDTECH C.P.R. MASK
- K Number
- K862199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The Medtech Group, Inc.
- Date Received
- June 10, 1986
- Decision Date
- June 13, 1986
- Product Code
- CAE
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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CUFFED OROPHARYNGEAL AIRWAY (COPA)
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RUSCH OPTOSAFE
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Other Clearances by The Medtech Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895203 | EN-TRAP SYRINGE | Oct 18, 1989 | Substantially Equivalent |