Transformer

FDA 510(k) K822267 · Kelleher Corp.

Substantially Equivalent

510(k) numberK822267

Submission

Device name
Transformer
Applicant
Kelleher Corp.
Mchenry, IL, US
Received
July 29, 1982
Decision date
October 13, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Kelleher Corp.

510(k)DeviceDecision
K822618Emergency Tracheostomy Instrument SetLJW · Traditional 01/28/1983SE
K822268Nagashima Ns-Iii ElectronystagmographGWN · Traditional 01/28/1983SE
K823083Electrosurgical UnitGEI · Traditional 12/07/1982SE
K823111Nystymograph AccessGNN · Traditional 11/22/1982SE
K822252ENT Treatment UnitsETF · Traditional 11/22/1982SE
K822272Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional 11/10/1982SE
K822017Tympanostomy Tubes & Various TypesETD · Traditional 10/27/1982SE
K822257Various Types of Light Source HandlesEOQ · Traditional 10/26/1982SE
K822259Laryngeal SpatulasEQH · Traditional 10/22/1982SE
K822004Face ShieldsKNT · Traditional 10/20/1982SE

Questions and answers

When was Transformer cleared by the FDA?

Transformer (K822267) received a 510(k) decision of Substantially Equivalent on October 13, 1982, 76 days after the submission was received.