MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR— 510(k) K961972
Substantially Equivalent - Subject to Tracking Reg.Aequitron Medical, Inc.
FDA 510(k) clearance K961972 for MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR, Substantially Equivalent - Subject to Tracking Reg. on 1997-04-18. Applicant: Aequitron Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Aequitron Medical, Inc.
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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