FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
K Number: K062230
·
Decision Aug 31, 2006
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
14
Review Days
29
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Basic Information
- Device Name
- MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
- K Number
- K062230
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Minrad, Inc.
- Date Received
- August 2, 2006
- Decision Date
- August 31, 2006
- Product Code
- CCW
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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Other Clearances by Minrad, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 | Aug 31, 2006 | Substantially Equivalent |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 | Nov 15, 2004 | Substantially Equivalent |
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| K981796 | LIGHT SABER CORE TISSUE NEEDLE | Aug 5, 1998 | Substantially Equivalent |