Anybattery C2 Rechargeable Battery

Electrocardiograph

Anybattery, Inc.

The following data is part of a premarket notification filed by Anybattery, Inc. with the FDA for Anybattery C2 Rechargeable Battery.

Pre-market Notification Details

• Device ID: K160667
• 510k Number: K160667
• Device Name: Anybattery C2 Rechargeable Battery
• Classification: Electrocardiograph
• Applicant: Anybattery, Inc. 2605 160th Street W #16 Rosemont, MN 55068
• Contact: Ed Speegle
• Correspondent: Claude Berthoin; Denterprise International, Inc./510k FDA Consulting 100 East Granade Blvd., Suite 219 Ormond Beach, FL 32176
• Product Code: DPS
• Subsequent Product Code: DRT
• Subsequent Product Code: DXN
• Subsequent Product Code: LDD
• Subsequent Product Code: MHX
• Subsequent Product Code: MOX
• Subsequent Product Code: MWI
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-09
• Decision Date: 2017-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00856096008280	K160667	000
00856096008136	K160667	000
00856096008129	K160667	000
00856096008112	K160667	000
00856096008105	K160667	000
00856096008099	K160667	000
00856096008082	K160667	000
00856096008075	K160667	000
00856096008068	K160667	000
00856096008051	K160667	000
00856096008044	K160667	000
00856096008037	K160667	000
00856096008020	K160667	000
00856096008143	K160667	000
00856096008150	K160667	000
00856096008273	K160667	000
00856096008266	K160667	000
00856096008259	K160667	000
00856096008242	K160667	000
00856096008235	K160667	000
00856096008228	K160667	000
00856096008211	K160667	000
00856096008204	K160667	000
00856096008198	K160667	000
00856096008181	K160667	000
00856096008174	K160667	000
00856096008167	K160667	000
00856096008013	K160667	000