Dantec Electronics, Inc.
Walker, MI, US
Dantec Electronics, Inc. appears in FDA device records in Walker, MI. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Dantec Electronics, Inc. between 1985 and 1990. The busiest year on record is 1988, with 4. The most recent is 1990, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | IKT | Substantially Equivalent | |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | GXZ | Substantially Equivalent | |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | FAP | Substantially Equivalent | |
| K881915 | DANTEC MAGNETIC STIMULATOR | GWF | Substantially Equivalent | |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | FAP | Substantially Equivalent | |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | FAP | Substantially Equivalent | |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | GXY | Substantially Equivalent | |
| K870567 | EVOPORT 300 | GWF | Substantially Equivalent | |
| K872106 | DANTEC COUNTERPOINT | GWF | Substantially Equivalent | |
| K860368 | URDYN 5000 (UROFLOWMETER) | FFO | Substantially Equivalent | |
| K853119 | URODYN 1000 | FFO | Substantially Equivalent | |
| K843815 | EVOMATIC 8000/4000 | GWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Dantec Electronics, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Dantec Electronics, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain