ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
FDA 510(k) clearance K973850 · decided 1997-11-12
Clearance details
- K-number
- K973850
- Device name
- ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007
- Applicant
- Alexander Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-08
- Decision date
- 1997-11-12
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HFO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mason City, IA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alexander Mfg. Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (K943989) | Gabris Surgical Corp. | 1994-09-12 |
| UC-2000 UTERINE CATHERIZATION SYSTEM (K791633) | Life Support, Inc. | 1979-09-17 |
| FETAL MONITORING SYSTEM (K780487) | Sonicaid, Inc. | 1978-05-09 |
Recalls involving this device
No recalls on record reference this clearance.