510(k) K010729
- Device
- AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A
- Applicant
- Andromed, Inc.
- 510(k) number
- K010729
- Product code
- DQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-26
- Date received
- 2001-03-12
- Regulation
- 870.1875
- Classification name
- Stethoscope, Electronic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- JULIA LALE AKTIK
- Address
- 4610 Chemin Du Bois-Franc Saint Laurent, Quebec CA H4S 1A7 H4S 1A7
FDA Registration Numbers#
- 3013557562
- 3010399798
- 3013689228
- 3003174284
- 3015907115
- 3030626857
- 3018117676
- 3002736372
- 3018783553
- 3017829091
- 3042167640
- 3038129050
- 3010097171
- 3007615597
- 3010262192
- 3010106598
- 1000548922
- 3031841433
- 3043226252
- 8010482
- 3024491912
- 3009756153
- 3008820594
- 3017394506
- 3004009431
- 3001149827
- 3011651230
- 3016678045
- 3012678246
- 3004582233
- 3036497156
- 3013757696
- 3012421607
- 1926681
- 3017026146
- 3012494290
- 3016864576
- 3009715978
- 3004215265
- 2434008
- 3011359729
- 3030310221
- 3000130829
- 3042272797
- 3008293988
- 3016442138
- 3015134086
Source Documents#
510(k) summary PDF not indicated by FDA
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