Miniclinic TM
FDA 510(k) K771922 · Instromedix, Inc.
510(k) numberK771922
Submission
- Device name
- Miniclinic TM
- Applicant
- Instromedix, Inc.
Mchenry, IL, US - Received
- October 13, 1977
- Decision date
- November 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
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| K964036 | Cardiomagic 2000 SoftwareDXH · Traditional | 07/18/1997SE |
| K955060 | Accelerated Transmission ProtocolDXH · Traditional | 04/08/1996SE |
| K951096 | Lifesigns Receiving Cener 2000 Transtelephonic ReceiverDXH · Traditional | 01/16/1996SE |
| K945476 | Hearthwatch Iii(Tm)DXH · Traditional | 11/09/1995SE |
| K950003 | Cardiomagic(R) Software EnhancementsDXH · Traditional | 10/31/1995SE |
| K944362 | Heartcard Cardiac Event MonitorDXH · Traditional | 09/07/1995SE |
| K943931 | Carryall EnhancementsDXH · Traditional | 04/04/1995SE |
| K935586 | PrinceDXH · Traditional | 11/08/1994SE |
Questions and answers
When was Miniclinic TM cleared by the FDA?
Miniclinic TM (K771922) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 20 days after the submission was received.
What is the product code of K771922?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.