510(k) K822269
- Device
- NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING
- Applicant
- KELLEHER CORP.
- 510(k) number
- K822269
- Product code
- EWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-09
- Date received
- 1982-07-29
- Regulation
- 874.1060
- Classification name
- Chamber, Acoustic (for Audiometric Testing)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9610612
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823872 | EMERGENCY TRACHEOSTOMY KIT | Omnicon Medical Corp. | 1983-01-21 |
Legacy Summary#
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FDA Review#
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