Lfre Indirect Laryngoscope
FDA 510(k) K023004 · Astralite Corp.
510(k) numberK023004
Submission
- Device name
- Lfre Indirect Laryngoscope
- Applicant
- Astralite Corp.
Van Nuys, CA, US - Received
- September 9, 2002
- Decision date
- January 28, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOB – Nasopharyngoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Lfre Indirect Laryngoscope cleared by the FDA?
Lfre Indirect Laryngoscope (K023004) received a 510(k) decision of Substantially Equivalent on January 28, 2003, 141 days after the submission was received.
What is the product code of K023004?
The FDA product code is EOB – Nasopharyngoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4760.