Reichert Flexible Laryngoscope, Model LS-11

FDA 510(k) K852994 · Reichert-Jung, Inc.

Substantially Equivalent

510(k) numberK852994

Submission

Device name
Reichert Flexible Laryngoscope, Model LS-11
Applicant
Reichert-Jung, Inc.
Southbridge, MA, US
Received
July 15, 1985
Decision date
July 29, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

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

510(k)DeviceApplicantDecision
K951195FI-10PCAL · Traditional Pentax Precision Instrument Corp.04/06/1995SE
K951194FI-10MCAL · Traditional Pentax Precision Instrument Corp.04/06/1995SE
K872895Haemonetics Cell Saver Mini Saver Auto. Blood Sys.CAL · Traditional Haemonetics Corp.01/11/1988SE
K850978Olympus LF-1 Intubation ScopeCAL · Traditional Olympus Corp.05/23/1985SE
K802331Ao Flexible Laryngoscope, #LS-7CAL · Traditional American Optical Corp.10/10/1980SE
K801364Ao Stylet Laryngoscope Model SLSCAL · Traditional American Optical Corp.06/17/1980SE
K791634Ao Stylet Laryngoscope, Model SLS-1CAL · Traditional American Optical Corp.09/17/1979SE

More from American Optical Corp.

510(k)DeviceDecision
K864821Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2EOB · Traditional 02/10/1987SE
K862551FUNS-10, FUNS-11FGB · Traditional 09/12/1986SE

Questions and answers

When was Reichert Flexible Laryngoscope, Model LS-11 cleared by the FDA?

Reichert Flexible Laryngoscope, Model LS-11 (K852994) received a 510(k) decision of Substantially Equivalent on July 29, 1985, 14 days after the submission was received.

What is the product code of K852994?

The FDA product code is CAL – Laryngoscope, Non-Rigid, a Class I (low risk) device regulated under 21 CFR 868.5530.