510(k) K221856
- Device
- BIOMONITOR IIIm, BIOMONITOR III
- Applicant
- BIOTRONIK, Inc.
- 510(k) number
- K221856
- Product code
- MXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-27
- Date received
- 2022-06-27
- Regulation
- 870.1025
- Classification name
- Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jon Brumbaugh
- Address
- 6024 Jean Rd. Lake Oswego OR US 97035 97035
FDA Registration Numbers#
- 2017865
- 9614453
- 3018094310
- 3004185781
- 3008973940
- 3009380063
- 2124215
- 9610139
- 9616693
- 2182208
- 1028232
- 3015544746
Source Documents#
Other 510(k) Records For Product Code MXD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | 2026-05-01 |
| K253516 | Assert-IQ (DM5100) | ABBOTT MEDICAL | 2025-12-18 |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott | 2025-09-17 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | Boston Scientific Corporation | 2025-09-12 |
| K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) | Medtronic, Inc. | 2024-03-28 |
| K233562 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2023-12-06 |
| K233320 | LINQ II™ Insertable Cardiac Monitor (LNQ22) | Medtronic, Inc. | 2023-10-31 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corp | 2023-08-19 |
| K230375 | BIOMONITOR IV | Biotronik, Inc. | 2023-05-19 |
| K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application | Medtronic, Inc. | 2023-04-26 |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | 2023-04-05 |
| K221962 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2022-08-25 |
| K212008 | Reveal LINQ Insertable Cardiac Monitor | Medtronic, Inc. | 2021-07-22 |
| K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 2021-06-11 |
| K211304 | LINQ II Insertable Cardiac Monitor | Medtronic, Inc. | 2021-05-28 |
Legacy Summary#
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FDA Review#
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