510(k) K243650
- Device
- Zio® monitor (DFG0001)
- Applicant
- iRhythm Technologies, Inc.
- 510(k) number
- K243650
- Product code
- DSH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-15
- Date received
- 2024-11-26
- Regulation
- 870.2800
- Classification name
- Recorder, Magnetic Tape, Medical
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Kiran Sorathia
- Address
- 699 8th St. Suite 600 San Francisco CA US 94103 94103
FDA Registration Numbers
- 3008773647
- 3004009431
- 9610816
- 1218950
- 3042167640
- 3030310221
- 8030978
- 3007663004
- 3014929383
- 1316463
- 3016812424
- 3013500228
- 9680510
- 3003263092
- 3000126629
- 3010342616
- 3024821700
- 3021332567
- 3006258337
- 3006733253
- 2132111
- 3003971136
- 3016701404
- 3006087789
- 3021769057
- 3009077524
- 3007208829
- 3026042935
- 3030721635
- 3024673
- 3009499478
- 3014522540
- 3012032144
- 3016618143
- 3002808458
- 3004035727
- 3008505660
- 3013889955
- 3005737664
- 3014271754
- 2133409
- 3029915537
- 3003584029
- 3014848734
- 3012528160
- 1527715
- 3007184699
- 3013596024
- 3043479346
- 3014226707
- 2017865
- 3014111150
- 3014235520
- 3010576710
- 3010082909
- 3010381606
Source Documents
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