Olympus LF-1 Intubation Scope
FDA 510(k) K850978 · Olympus Corp.
510(k) numberK850978
Submission
- Device name
- Olympus LF-1 Intubation Scope
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- March 8, 1985
- Decision date
- May 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAL – Laryngoscope, Non-Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5530
- Specialty
- Anesthesiology
Other 510(k)s with product code CAL
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|---|---|---|---|
| K951195 | FI-10PCAL · Traditional | Pentax Precision Instrument Corp. | 04/06/1995SE |
| K951194 | FI-10MCAL · Traditional | Pentax Precision Instrument Corp. | 04/06/1995SE |
| K872895 | Haemonetics Cell Saver Mini Saver Auto. Blood Sys.CAL · Traditional | Haemonetics Corp. | 01/11/1988SE |
| K852994 | Reichert Flexible Laryngoscope, Model LS-11CAL · Traditional | Reichert-Jung, Inc. | 07/29/1985SE |
| K802331 | Ao Flexible Laryngoscope, #LS-7CAL · Traditional | American Optical Corp. | 10/10/1980SE |
| K801364 | Ao Stylet Laryngoscope Model SLSCAL · Traditional | American Optical Corp. | 06/17/1980SE |
| K791634 | Ao Stylet Laryngoscope, Model SLS-1CAL · Traditional | American Optical Corp. | 09/17/1979SE |
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Questions and answers
When was Olympus LF-1 Intubation Scope cleared by the FDA?
Olympus LF-1 Intubation Scope (K850978) received a 510(k) decision of Substantially Equivalent on May 23, 1985, 76 days after the submission was received.
What is the product code of K850978?
The FDA product code is CAL – Laryngoscope, Non-Rigid, a Class I (low risk) device regulated under 21 CFR 868.5530.