FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
K Number: K821181
·
Decision May 13, 1982
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
8
Review Days
16
Basic Information
- Device Name
- FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
- K Number
- K821181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- MACHIDA AMERICA, INC.
- Date Received
- April 27, 1982
- Decision Date
- May 13, 1982
- Product Code
- EQN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by MACHIDA AMERICA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | Jan 14, 1988 | Substantially Equivalent |
| K854581 | MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 | Feb 28, 1986 | Substantially Equivalent |
| K844834 | MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 | Jun 11, 1985 | Substantially Equivalent |
| K841087 | FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 | May 16, 1984 | Substantially Equivalent |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | May 13, 1982 | Substantially Equivalent |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | Oct 19, 1981 | Substantially Equivalent |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | Jul 28, 1981 | Substantially Equivalent |