FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LARYNGOSCOPE
K Number: K851705
·
Decision May 21, 1985
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
5
Review Days
26
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Basic Information
- Device Name
- LARYNGOSCOPE
- K Number
- K851705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Armstrong Ind., Inc.
- Date Received
- April 25, 1985
- Decision Date
- May 21, 1985
- 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 Armstrong Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852281 | SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER | Oct 9, 1985 | Substantially Equivalent |
| K852181 | ELECTROCARDIOGRAPH | Oct 9, 1985 | Substantially Equivalent |
| K852282 | SCHILLER MINISCOPE MS-2 EKG SCOPE | Oct 9, 1985 | Substantially Equivalent |
| K822727 | RESCUER | Sep 28, 1982 | Substantially Equivalent |