APOLLO

Densitometer, Bone

NORLAND CORP.

The following data is part of a premarket notification filed by Norland Corp. with the FDA for Apollo.

Pre-market Notification Details

• Device ID: K972882
• 510k Number: K972882
• Device Name: APOLLO
• Classification: Densitometer, Bone
• Applicant: NORLAND CORP. WEST 6340 HACKBARTH RD. Fort Atkinson, WI 53538 -8999
• Contact: Terry Schwalengerg
• Correspondent: John Monahan; NORLAND CORP. 31 Gordan Road Piscataway, NJ 08854
• Product Code: KGI
• CFR Regulation Number: 892.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-05
• Decision Date: 1997-10-31
• Summary: summary