Labeltape Meditect, Inc.
Grand Rapids, MI, US
Labeltape Meditect, Inc. appears in FDA device records in Grand Rapids, MI. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Labeltape Meditect, Inc. between 1986 and 1995. The busiest year on record is 1987, with 7. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1987 | 7 |
| 1988 | 3 |
| 1989 | 5 |
| 1990 | 5 |
| 1991 | 2 |
| 1992 | 1 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD | GEI | Substantially Equivalent | |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | GXY | Substantially Equivalent | |
| K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL | GZJ | Substantially Equivalent | |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | KHE | Substantially Equivalent | |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | DRX | Substantially Equivalent | |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | GXY | Substantially Equivalent | |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | GXY | Substantially Equivalent | |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | GXY | Substantially Equivalent | |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | GXY | Substantially Equivalent | |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | DRX | Substantially Equivalent | |
| K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER | DRX | Substantially Equivalent | |
| K894043 | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS | GXY | Substantially Equivalent | |
| K894042 | SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS | GXY | Substantially Equivalent | |
| K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST | KHE | Substantially Equivalent | |
| K880649 | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING | GXY | Substantially Equivalent | |
| K875041 | FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE | DRX | Substantially Equivalent | |
| K872866 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) | DRX | Substantially Equivalent | |
| K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) | DRX | Substantially Equivalent | |
| K874628 | RESUBMITTED STANDARD MICROPORE ECG ELECTRODE | DRX | Substantially Equivalent | |
| K872869 | STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) | DXH | Substantially Equivalent | |
| K872871 | NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) | DRX | Substantially Equivalent | |
| K871026 | DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS | GXY | Substantially Equivalent | |
| K865011 | PREGELLED DISPOSABLE ELECTRODE, SILVER-SILVER | DRX | Substantially Equivalent | |
| K865090 | PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE | Substantially Equivalent | ||
| K863366 | PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE | DRX | Substantially Equivalent | |
| K862756 | PREGELLED INFANT DISPOSABLE ECG ELECTRODE | DXN | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain