FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LASER - 1000

K Number: K882436 · Decision Aug 4, 1988
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
7
Review Days
51

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Basic Information

Device Name
LASER - 1000
K Number
K882436
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.1800
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Panoramic Corp.
Date Received
June 14, 1988
Decision Date
August 4, 1988
Product Code
EHD
Advisory Committee
Dental
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EHD Unit, X-Ray, Extraoral With Timer

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K110371 ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY
K043557 MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
K943532 PANORAMIC CORPORATION HDLX
K870236 PANORAMIC X-RAY MODEL PC-1000