FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EZ-MISTER
K Number: K093584
·
Decision Mar 4, 2011
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
5
Review Days
470
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Basic Information
- Device Name
- EZ-MISTER
- K Number
- K093584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5170
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- N.M. Beale Co., Inc.
- Date Received
- November 19, 2009
- Decision Date
- March 4, 2011
- Product Code
- CCT
- 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 |
|---|---|---|---|
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | FDA class 2 | Anesthesiology |
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Other Clearances by N.M. Beale Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093329 | SCOPE INTRODUCER MODEL 7400 | Feb 16, 2010 | Substantially Equivalent |
| K071579 | PEF TUBE | Nov 20, 2007 | Substantially Equivalent |
| K992178 | BALLOON FOR ULTRASONIC ENDOSCOPES | May 12, 2000 | Substantially Equivalent |
| K903834 | N. M. BEALE COMPANY VU-THRU WATER BOTTLE | Sep 24, 1990 | Substantially Equivalent |