Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
| Device Type ID | 188 |
| Device Name | Laryngoscope Kit |
| Physical State | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Technical Method | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Target Area | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen |
| Regulation Description | Rigid Laryngoscope. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 868.5540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OGH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 188 |
| Device | Laryngoscope Kit |
| Product Code | OGH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rigid Laryngoscope. |
| CFR Regulation Number | 868.5540 [🔎] |
| Device Problems | |
|---|---|
Failure To Conduct | 5 |
Optical Problem | 4 |
Inadequate Lighting | 3 |
Connection Problem | 1 |
Device Inoperable | 1 |
Device Operates Differently Than Expected | 1 |
Poor Quality Image | 1 |
Fitting Problem | 1 |
Break | 1 |
| Total Device Problems | 18 |