Andover Medical, Inc.
Mchenry, IL, US
Andover Medical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Andover Medical, Inc. between 1976 and 1991. The busiest year on record is 1984, with 4. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 3 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 4 |
| 1986 | 4 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905729 | CANMED 451 | DRX | Substantially Equivalent | |
| K903427 | NORTECH MODEL 86901000 ELECTRODE | GXY | Substantially Equivalent | |
| K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE | DRO | Substantially Equivalent | |
| K860636 | FASTRACE III, ECG ELECTRODE | DPS | Substantially Equivalent | |
| K854433 | ECG MONITORING/DEFIBRILLATION ELECTRODE | DRX | Substantially Equivalent | |
| K860535 | UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) | CAT | Substantially Equivalent | |
| K860283 | AMI CARDIO-PAD | DRO | Substantially Equivalent | |
| K843412 | FLOW DIRECTED THERMODILUTION CATH W/VEN | KRB | Substantially Equivalent | |
| K843410 | FLOW-DIRECTED PEDIATRIC THERMODIL- CATH | KRB | Substantially Equivalent | |
| K843411 | THERMAL DILUTION CATHETER | DYG | Substantially Equivalent | |
| K843409 | FLOW-DIRECTED THERMODILUTION CATH | DYG | Substantially Equivalent | |
| K831785 | NEURO EASE | GXY | Substantially Equivalent | |
| K823414 | HOLTER KIT MODEL #5000 SERIES | DSH | Substantially Equivalent | |
| K822798 | DISPOSABLE ELECTRODE #1900 | DRX | Substantially Equivalent | |
| K812878 | THE NEW 1600 ELECTRODE | DRX | Substantially Equivalent | |
| K812276 | DISPOSABLE ELECTRODE, #1610 | DRX | Substantially Equivalent | |
| K810271 | DIRECT CURRENT BONE GROWTH STIM. AN. PAD | Substantially Equivalent | ||
| K790316 | ELECTRODE, ELECTROFLEX | GXY | Substantially Equivalent | |
| K780908 | SELF-RETAINING ELECTRODE SER. #4000-100 | DRX | Substantially Equivalent | |
| K760358 | ELECTRODE SERIES 1600 | DRX | Substantially Equivalent | |
| K760280 | ELECTRODE SERIES 1401 | DRX | 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